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    Clinical Trial Results:
    A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K delta Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia (topMIND)

    Summary
    EudraCT number
    		 2020-005591-35
    Trial protocol
    		 FR   IT   ES   AT   BE  
    Global end of trial date
    22 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2025
    First version publication date
    06 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCMOR 0208-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 855-463-3463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 855-463-3463, medinfo@incyte.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The dose confirmation period (Phase 1b was conducted to determine the safety, tolerability, and dose-limiting toxicities of combination therapy with tafasitamab plus parsaclisib in participants with relapsed or refractory (R/R) B-cell malignancies who were previously treated with at least two prior lines of systemic anti-lymphoma therapy. The dose expansion period (Phase 2a) was conducted to assess the preliminary efficacy of combination therapy with tafasitamab plus parsaclisib in participants with R/R B-cell malignancies who were previously treated with at least two prior lines of systemic anti-lymphoma therapy.
    Protection of trial subjects
    This study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was being conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Italy: 28
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    17
    From 65 to 84 years
    36
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled across 16 sites in Austria, Belgium, Spain, France, and Italy.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: R/R DLBCL
    Arm description
    		 Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose formulation: 1 mg, 2.5 mg, 5 mg, and 20 mg tablets. Unit dose strength(s)/dosage level(s): 20 mg, 10 mg 2.5 mg, 1 mg

    Investigational medicinal product name
    tafasitamab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg lyophilized powder in single-dose 20-mL vial for reconstitution and dilution

    Arm title
    		 Cohort 2: R/R MCL
    Arm description
    		 Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose formulation: 1 mg, 2.5 mg, 5 mg, and 20 mg tablets. Unit dose strength(s)/dosage level(s): 20 mg, 10 mg 2.5 mg, 1 mg

    Investigational medicinal product name
    tafasitamab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg lyophilized powder in single-dose 20-mL vial for reconstitution and dilution

    Arm title
    		 Cohort 3: R/R FL
    Arm description
    		 Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose formulation: 1 mg, 2.5 mg, 5 mg, and 20 mg tablets. Unit dose strength(s)/dosage level(s): 20 mg, 10 mg 2.5 mg, 1 mg

    Investigational medicinal product name
    tafasitamab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg lyophilized powder in single-dose 20-mL vial for reconstitution and dilution

    Arm title
    		 Cohort 4: R/R MZL
    Arm description
    		 Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose formulation: 1 mg, 2.5 mg, 5 mg, and 20 mg tablets. Unit dose strength(s)/dosage level(s): 20 mg, 10 mg 2.5 mg, 1 mg

    Investigational medicinal product name
    tafasitamab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg lyophilized powder in single-dose 20-mL vial for reconstitution and dilution

    Arm title
    		 Cohort 5: R/R CLL/SLL
    Arm description
    		 Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose formulation: 1 mg, 2.5 mg, 5 mg, and 20 mg tablets. Unit dose strength(s)/dosage level(s): 20 mg, 10 mg 2.5 mg, 1 mg

    Investigational medicinal product name
    tafasitamab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg lyophilized powder in single-dose 20-mL vial for reconstitution and dilution

    Number of subjects in period 1
    		Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
    Started
    15
    11
    21
    3
    4
    Completed
    0
    0
    0
    0
    0
    Not completed
    15
    11
    21
    3
    4
         Adverse event, serious fatal
    9
    7
    4
    -
    1
         Consent withdrawn by subject
    2
    1
    3
    1
    -
         New Treatment per Principal Investigator
    -
    -
    1
    -
    -
         Sponsor Terminated Collection of Follow-up Data
    3
    2
    10
    1
    2
         Medical Decision: Worsening Clinical Condition
    1
    -
    -
    -
    -
         Transitioned to Rollover Protocol
    -
    1
    2
    -
    1
         Lost to follow-up
    -
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: R/R DLBCL
    Reporting group description
    		 Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 2: R/R MCL
    Reporting group description
    		 Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 3: R/R FL
    Reporting group description
    		 Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 4: R/R MZL
    Reporting group description
    		 Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 5: R/R CLL/SLL
    Reporting group description
    		 Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group values
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL Total
    Number of subjects
    		 15 11 21 3 4 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 4 3 8 1 1 17
        From 65-84 years
    		 11 7 13 2 3 36
        85 years and over
    		 0 1 0 0 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.2 ( 15.47 ) 68.9 ( 15.06 ) 66.8 ( 8.03 ) 65.7 ( 17.21 ) 70.3 ( 5.74 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 5 1 11 3 2 22
        Male
    		 10 10 10 0 2 32
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0
        White
    		 14 9 18 3 3 47
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 1 2 3 0 1 7
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 3 2 1 0 7
        Not Hispanic or Latino
    		 13 6 16 2 2 39
        Unknown or Not Reported
    		 1 2 3 0 2 8

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: R/R DLBCL
    Reporting group description
    		 Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 2: R/R MCL
    Reporting group description
    		 Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 3: R/R FL
    Reporting group description
    		 Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 4: R/R MZL
    Reporting group description
    		 Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 5: R/R CLL/SLL
    Reporting group description
    		 Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Subject analysis set title
    All Cohorts
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants with R/R DLBCL, R/R, MCL, R/R FL, R/R MZL, and CLL/SLL received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Primary: Phase 1b: Number of participants with any ≥Grade 3 TEAE

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    End point title
    		 Phase 1b: Number of participants with any ≥Grade 3 TEAE [1]
    End point description
    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
    End point type
    Primary
    End point timeframe
    up to 1092 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
    Number of subjects analysed
    15 [2]
    11 [3]
    21 [4]
    3 [5]
    4 [6]
    Units: participants
    12
    9
    18
    3
    2
    Notes
    [2] - Full Analysis Set
    [3] - Full Analysis Set
    [4] - Full Analysis Set
    [5] - Full Analysis Set
    [6] - Full Analysis Set
    No statistical analyses for this end point

    Primary: Phase 1b: Number of participants with dose-limiting toxicities (DLTs)

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    End point title
    		 Phase 1b: Number of participants with dose-limiting toxicities (DLTs) [7]
    End point description
    A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation. DLT Evaluable Population: all participants who received at least 3 of 4 doses of tafasitamab and 21 days of treatment with parsaclisib 20 mg QD during the first cycle (28 days) or experienced a DLT.
    End point type
    Primary
    End point timeframe
    up to 28 days
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
    Number of subjects analysed
    15 [8]
    11 [9]
    21 [10]
    3 [11]
    4 [12]
    Units: participants
    0
    0
    0
    0
    0
    Notes
    [8] - DLT Evaluable Population
    [9] - DLT Evaluable Population
    [10] - DLT Evaluable Population
    [11] - DLT Evaluable Population
    [12] - DLT Evaluable Population
    No statistical analyses for this end point

    Primary: Phase 1b: Number of participants with any treatment-emergent adverse event (TEAE )

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    End point title
    		 Phase 1b: Number of participants with any treatment-emergent adverse event (TEAE ) [13]
    End point description
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. Full Analysis Set: all participants who received at least 1 dose of tafasitamab or parsaclisib.
    End point type
    Primary
    End point timeframe
    up to 1092 days
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
    Number of subjects analysed
    15 [14]
    11 [15]
    21 [16]
    3 [17]
    4 [18]
    Units: participants
    15
    11
    21
    3
    4
    Notes
    [14] - Full Analysis Set
    [15] - Full Analysis Set
    [16] - Full Analysis Set
    [17] - Full Analysis Set
    [18] - Full Analysis Set
    No statistical analyses for this end point

    Primary: Phase 2a: Objective response rate based on investigator assessment: percentage of participants with CR/CMR or PR/PMR according to Lugano criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL

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    End point title
    		 Phase 2a: Objective response rate based on investigator assessment: percentage of participants with CR/CMR or PR/PMR according to Lugano criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL [19]
    End point description
    Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size <13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.
    End point type
    Primary
    End point timeframe
    up to 1002 days
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
    Number of subjects analysed
    15 [20]
    11 [21]
    21 [22]
    3 [23]
    4 [24]
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (11.8 to 61.6)
    81.8 (48.2 to 97.7)
    90.5 (69.6 to 98.8)
    33.3 (0.8 to 90.6)
    50.0 (6.8 to 93.2)
    Notes
    [20] - Full Analysis Set. CIs were calculated based on the exact method for binomial distributions.
    [21] - Full Analysis Set. CIs were calculated based on the exact method for binomial distributions.
    [22] - Full Analysis Set. CIs were calculated based on the exact method for binomial distributions.
    [23] - Full Analysis Set. CIs were calculated based on the exact method for binomial distributions.
    [24] - Full Analysis Set. CIs were calculated based on the exact method for binomial distributions.
    No statistical analyses for this end point

    Secondary: Cmax of tafasitamab when given in combination with parsaclisib

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    End point title
    		 Cmax of tafasitamab when given in combination with parsaclisib
    End point description
    Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose. Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of tafasitamab or parsaclisib and provided at least 1 postdose PK plasma sample.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    53 [25]
    Units: milligrams per liter (mg/L)
        arithmetic mean (standard deviation)
    324.203 ( 112.746 )
    Notes
    [25] - PK Evaluable Population
    No statistical analyses for this end point

    Secondary: tmax of tafasitamab when given in combination with parsaclisib

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    End point title
    		 tmax of tafasitamab when given in combination with parsaclisib
    End point description
    tmax was defined as the time to the maximum concentration of tafasitamab. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    53 [26]
    Units: hours
        arithmetic mean (standard deviation)
    3.963 ( 1.591 )
    Notes
    [26] - PK Evaluable Population
    No statistical analyses for this end point

    Secondary: AUClast of tafasitamab when given in combination with parsaclisib

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    End point title
    		 AUClast of tafasitamab when given in combination with parsaclisib
    End point description
    AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    53 [27]
    Units: hours x mg/L
        arithmetic mean (standard deviation)
    31379.84 ( 12369.81 )
    Notes
    [27] - PK Evaluable Population
    No statistical analyses for this end point

    Secondary: Clast of tafasitamab when given in combination with parsaclisib

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    End point title
    		 Clast of tafasitamab when given in combination with parsaclisib
    End point description
    AUC0-inf was defined as the last measurable plasma drug concentration. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    53 [28]
    Units: mg/L
        arithmetic mean (standard deviation)
    114.386 ( 56.789 )
    Notes
    [28] - PK Evaluable Population
    No statistical analyses for this end point

    Secondary: t1/2 of tafasitamab when given in combination with parsaclisib

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    End point title
    		 t1/2 of tafasitamab when given in combination with parsaclisib
    End point description
    t1/2 was defined as the drug's elimination half-life, which is the time it takes for the concentration of a drug in the body to decrease by 50%. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    51 [29]
    Units: hours
        arithmetic mean (standard deviation)
    121.702 ( 49.506 )
    Notes
    [29] - PK Evaluable Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: AUC0-inf of tafasitamab when given in combination with parsaclisib

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    End point title
    		 AUC0-inf of tafasitamab when given in combination with parsaclisib
    End point description
    AUC0-inf was defined as the area under the plasma concentration-time curve from time zero to infinity (time that the drug is no longer present in the body). Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    51 [30]
    Units: hours x mg/L
        arithmetic mean (standard deviation)
    54825.21 ( 29363.32 )
    Notes
    [30] - PK Evaluable Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: CL of tafasitamab when given in combination with parsaclisib

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    End point title
    		 CL of tafasitamab when given in combination with parsaclisib
    End point description
    CL was defined as the apparent total body clearance of drug from plasma. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    51 [31]
    Units: liter per hour
        arithmetic mean (standard deviation)
    0.021 ( 0.015 )
    Notes
    [31] - PK Evaluable Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: VZ of tafasitamab when given in combination with parsaclisib

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    End point title
    		 VZ of tafasitamab when given in combination with parsaclisib
    End point description
    Vz was defined as the volume of distribution. Samples were collected for pharmacokinetic analysis at the following times: Cyle 1 Day 1 (C1D1): predose; immediately after tafasitamab infusion; 1 and 4 hours (hr) postinfusion. C1D8, C1D15, C1D22: predose; immediately after tafasitamab infusion; 1 hr postinfusion. C2D1, C2D15, C3D1, C3D15: predose; 1 hr postinfusion. C4D1 and every 4 cycles thereafter (C8D1, C12D1, etc.): predose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15; Cycle 3 Days 1 and 15; Cycle 4 Day 1 and every 4 cycles thereafter (Cycle 8 Day 1, Cycle 12 Day 1, etc.)
    End point values
    		 All Cohorts
    Number of subjects analysed
    51 [32]
    Units: liters
        arithmetic mean (standard deviation)
    3.254 ( 1.694 )
    Notes
    [32] - PK Evaluable Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 1092 days
    Adverse event reporting additional description
    Adverse events have been reported for the Full Analysis Set, comprised of all participants who received at least 1 dose of tafasitamab or parsaclisib.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Cohort 1: R/R DLBCL
    Reporting group description
    		 Participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) received tafasitamab administered at 12 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg once daily (QD) for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 2: R/R MCL
    Reporting group description
    		 Participants with R/R mantle cell lymphoma (MCL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 5: R/R CLL/SLL
    Reporting group description
    		 Participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 4: R/R MZL
    Reporting group description
    		 Participants with R/R marginal zone lymphoma (MZL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Reporting group title
    Cohort 3: R/R FL
    Reporting group description
    		 Participants with R/R follicular lymphoma (FL) received tafasitamab administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Participants also self-administered parsaclisib at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter. Study treatment was administered until progression of disease, withdrawal of consent, or unacceptable toxicity.

    Serious adverse events
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 5: R/R CLL/SLL Cohort 4: R/R MZL Cohort 3: R/R FL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
    7 / 11 (63.64%)
    3 / 4 (75.00%)
    2 / 3 (66.67%)
    12 / 21 (57.14%)
         number of deaths (all causes)
    9
    7
    1
    0
    4
         number of deaths resulting from adverse events
    2
    3
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lung neoplasm
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 11 (18.18%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Xerosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    6 / 21 (28.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin exfoliation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    3 / 21 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    COVID-19
         subjects affected / exposed
    1 / 15 (6.67%)
    4 / 11 (36.36%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 5: R/R CLL/SLL Cohort 4: R/R MZL Cohort 3: R/R FL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    11 / 11 (100.00%)
    4 / 4 (100.00%)
    3 / 3 (100.00%)
    21 / 21 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    POEMS syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    4
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 15 (33.33%)
    3 / 11 (27.27%)
    2 / 4 (50.00%)
    1 / 3 (33.33%)
    6 / 21 (28.57%)
         occurrences all number
    5
    6
    3
    1
    7
    Face oedema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    0
    1
    0
    2
    General physical health deterioration
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    2
    2
    0
    0
    4
    Pyrexia
         subjects affected / exposed
    3 / 15 (20.00%)
    3 / 11 (27.27%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    6 / 21 (28.57%)
         occurrences all number
    5
    3
    0
    0
    9
    Xerosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    0
    1
    Immune system disorders
    Graft versus host disease in skin
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Graft versus host disease in liver
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Testicular oedema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    2 / 15 (13.33%)
    4 / 11 (36.36%)
    3 / 4 (75.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    3
    6
    4
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    2
    Pneumonitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 11 (27.27%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    3
    1
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    Amylase increased
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    1
    1
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    0
    1
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    1
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    0
    1
    Pelvic bone injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    3
    Dysgeusia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    0
    3
    Dysgraphia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    0
    0
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Anaemia
         subjects affected / exposed
    2 / 15 (13.33%)
    4 / 11 (36.36%)
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    5
    3
    0
    2
    Cytopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    Eosinophilia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    1
    Lymphocytosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    7 / 15 (46.67%)
    6 / 11 (54.55%)
    0 / 4 (0.00%)
    3 / 3 (100.00%)
    11 / 21 (52.38%)
         occurrences all number
    12
    11
    0
    3
    19
    Thrombocytopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    7 / 11 (63.64%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    8
    1
    0
    4
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Xerophthalmia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    4
    3
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 11 (18.18%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    1
    0
    2
    Dyspepsia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    4 / 21 (19.05%)
         occurrences all number
    0
    0
    1
    0
    4
    Colitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    4 / 15 (26.67%)
    2 / 11 (18.18%)
    2 / 4 (50.00%)
    2 / 3 (66.67%)
    11 / 21 (52.38%)
         occurrences all number
    6
    2
    2
    3
    15
    Frequent bowel movements
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    5 / 21 (23.81%)
         occurrences all number
    1
    1
    1
    0
    9
    Oesophagitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Retching
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    1
    2
    0
    3
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    0
    1
    2
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    4 / 21 (19.05%)
         occurrences all number
    0
    1
    1
    1
    4
    Rash pruritic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin induration
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    0
    0
    2
    Renal failure
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    1
    0
    0
    4
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    5 / 21 (23.81%)
         occurrences all number
    0
    0
    4
    0
    5
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 15 (20.00%)
    1 / 11 (9.09%)
    2 / 4 (50.00%)
    1 / 3 (33.33%)
    8 / 21 (38.10%)
         occurrences all number
    4
    2
    2
    1
    10
    Campylobacter colitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    1
    0
    0
    2
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    1
    0
    0
    4
    Gastroenteritis viral
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haemophilus infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    0
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    1
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 11 (18.18%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    4
    1
    0
    2
    Vascular device infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    1
    Decreased appetite
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 11 (9.09%)
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    2
    3
    2
    0
    4
    Cell death
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    5 / 21 (23.81%)
         occurrences all number
    1
    0
    0
    0
    5
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    0
    0
    0
    4
    Hypophosphataemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    2
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2021
    The primary purpose of the amendment was to modify the operating characteristics of the internal Data Safety Monitoring Board (iDSMB), update the time interval that must have elapsed before performing the safety follow-up visit, and update the biomarker sample collection. schedule.
    13 Sep 2022
    The primary purpose of this amendment was to include sponsor recommendations regarding coronavirus disease 2019 (COVID-19) monitoring and management, to update data privacy requirements in accordance with the European Union (EU) Clinical Trials Regulation directive, and to include revisions made in administrative changes.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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