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    Clinical Trial Results:
    A phase I/Ib open-label, multi-center dose escalation study of JBH492 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL)

    Summary
    EudraCT number
    		 2019-002666-12
    Trial protocol
    		 FI   DE  
    Global end of trial date
    05 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2025
    First version publication date
    19 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CJBH492A12101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04240704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Lichtstrasse 35, Basel, Switzerland, 4056
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    05 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To characterize safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of JBH492 single agent in participants with relapsed/refractory (r/r) CLL and r/r NHL.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Israel: 2
    Worldwide total number of subjects
    25
    EEA total number of subjects
    17
    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)
    10
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in 8 investigative sites in 7 countries.

    Pre-assignment
    Screening details
    		 The screening period began once patients had signed the study informed consent. Screening evaluations had to be completed within 28 days prior to the first dose of study treatment. After screening, the treatment period started on Cycle 1 Day 1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JBH492 0.4 mg/kg
    Arm description
    		 JBH492 0.4 mg/kg intravenously once every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    JBH492
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.4 mg/Kg once every 3 weeks

    Arm title
    		 JBH492 0.8 mg/kg
    Arm description
    		 JBH492 0.8 mg/kg intravenously once every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    JBH492
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.8 mg/Kg once every 3 weeks

    Arm title
    		 JBH492 1.6mg/kg
    Arm description
    		 JBH492 1.6 mg/kg intravenously once every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    JBH492
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.6 mg/Kg once every 3 weeks

    Arm title
    		 JBH492 2.4mg/kg
    Arm description
    		 JBH492 2.4 mg/kg intravenously once every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    JBH492
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2.4 mg/Kg once every 3 weeks

    Arm title
    		 JHB492 3.6mg/kg
    Arm description
    		 JBH492 3.6 mg/kg intravenously once every 3 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    JBH492
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3.6 mg/Kg once every 3 weeks

    Number of subjects in period 1
    		JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Started
    4
    3
    5
    7
    6
    Completed
    0
    0
    0
    0
    0
    Not completed
    4
    3
    5
    7
    6
         Participant decision
    -
    -
    -
    -
    1
         Death
    1
    -
    -
    1
    -
         Adverse event
    -
    -
    -
    -
    2
         Progressive disease
    3
    3
    5
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JBH492 0.4 mg/kg
    Reporting group description
    		 JBH492 0.4 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 0.8 mg/kg
    Reporting group description
    		 JBH492 0.8 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 1.6mg/kg
    Reporting group description
    		 JBH492 1.6 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 2.4mg/kg
    Reporting group description
    		 JBH492 2.4 mg/kg intravenously once every 3 weeks

    Reporting group title
    JHB492 3.6mg/kg
    Reporting group description
    		 JBH492 3.6 mg/kg intravenously once every 3 weeks

    Reporting group values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg Total
    Number of subjects
    		 4 3 5 7 6 25
    Age Categorical
    Units: Participants
        18 - < 65 years
    		 1 0 2 3 4 10
        65 - < 85 years
    		 2 3 3 4 2 14
        >= 85 years
    		 1 0 0 0 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 75 ( 9.06 ) 71 ( 3.61 ) 64.4 ( 10.36 ) 65.1 ( 10.09 ) 59.5 ( 13.81 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 2 0 1 3 2 8
        Male
    		 2 3 4 4 4 17
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 1 1 2 1 1 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 1 1 2
        White
    		 3 2 3 5 4 17
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    JBH492 0.4 mg/kg
    Reporting group description
    		 JBH492 0.4 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 0.8 mg/kg
    Reporting group description
    		 JBH492 0.8 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 1.6mg/kg
    Reporting group description
    		 JBH492 1.6 mg/kg intravenously once every 3 weeks

    Reporting group title
    JBH492 2.4mg/kg
    Reporting group description
    		 JBH492 2.4 mg/kg intravenously once every 3 weeks

    Reporting group title
    JHB492 3.6mg/kg
    Reporting group description
    		 JBH492 3.6 mg/kg intravenously once every 3 weeks

    Subject analysis set title
    Low dose JBH492 0.4/0.8/1.6 mg/kg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    JBH492 0.4, 0.8 and 1.6 mg/kg intravenously once every 3 weeks

    Subject analysis set title
    High dose JBH492 2.4/3.6 mg/kg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    JBH492 2.4 and 3.6 mg/kg intravenously once every 3 weeks

    Primary: Number of participants with dose limiting toxicities (DLTs)

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    End point title
    		 Number of participants with dose limiting toxicities (DLTs) [1]
    End point description
    A dose-limiting toxicity (DLT) is defined as an adverse event (AE) or abnormal laboratory value that occurs during the first cycle of treatment with JBH492 and meets any of the protocol specified criteria, unless incontrovertibly related to underlying disease, intercurrent illness or concomitant medications. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    First cycle of treatment (21 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    3
    3
    5
    7
    5
    Units: Participants
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with on treatment Adverse Events (AEs)

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    End point title
    		 Number of participants with on treatment Adverse Events (AEs) [2]
    End point description
    An adverse event ( treatment emergent) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient’s signed informed consent has been obtained. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    From treatment day 1 until 30 days post last treatment up to approximately 1.6 years
    Notes
    [2] - 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: Participants
        AEs
    4
    3
    5
    7
    5
        AEs suspected to be treatment related
    1
    1
    3
    6
    5
        AEs requiring additional therapy
    3
    2
    3
    5
    5
    No statistical analyses for this end point

    Primary: Number of participants with on treatment Serious Adverse Events (SAEs)

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    End point title
    		 Number of participants with on treatment Serious Adverse Events (SAEs) [3]
    End point description
    A Serious adverse event (SAE) is defined as one of the following: • Is fatal or life-threatening • Results in persistent or significant disability/incapacity • Constitutes a congenital anomaly/birth defect • Is medically significant • Requires inpatient hospitalization or prolongation of existing hospitalization. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    From treatment day 1 until 30 days post last treatment up to approximately 1.6 years
    Notes
    [3] - 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: Participants
        SAEs
    1
    1
    0
    2
    3
        SAEs suspected to be treatment related
    0
    0
    0
    0
    2
    No statistical analyses for this end point

    Primary: Number of participants with dose interruptions and dose reductions

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    End point title
    		 Number of participants with dose interruptions and dose reductions [4]
    End point description
    Tolerability measured by the number of subjects who have interruptions or reductions of study treatment. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    From first dose of study treatment until last dose up to approximately 1.5 years
    Notes
    [4] - 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: Participants
        At least one dose reduction or interruption
    0
    0
    0
    3
    2
        Participants with at least one dose reduction
    0
    0
    0
    1
    2
        Participants with at least one dose interruption
    0
    0
    0
    2
    0
    No statistical analyses for this end point

    Primary: Cumulative dose

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    End point title
    		 Cumulative dose [5]
    End point description
    Tolerability was measured by the cumulative dose of study drug. Cumulative dose is defined as the total dose given during the study treatment exposure. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    From first dose of study treatment until last dose up to approximately 1.5 years
    Notes
    [5] - 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: mg/Kg
        median (full range (min-max))
    1.00 (0.4 to 1.2)
    0.80 (0.8 to 0.8)
    4.80 (1.6 to 9.6)
    16.80 (2.4 to 45.6)
    7.20 (3.6 to 57.6)
    No statistical analyses for this end point

    Primary: Relative dose intensity

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    End point title
    		 Relative dose intensity [6]
    End point description
    Tolerability was measured by the relative dose intensity of study drug. Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intensity. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    From baseline until last dose os study treatment up to approximately 1.5 years
    Notes
    [6] - 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: No statistical hypothesis testing was planned for this primary endpoint
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: Ratio
        median (full range (min-max))
    1.000 (1.00 to 1.00)
    1.000 (1.00 to 1.00)
    1.000 (1.00 to 1.00)
    1.000 (1.00 to 1.00)
    1.000 (1.00 to 1.00)
    No statistical analyses for this end point

    Secondary: Best overall response (BOR) in CLL participants

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    End point title
    		 Best overall response (BOR) in CLL participants
    End point description
    The best overall response (BOR) is the best response recorded in a patient from the start of treatment until disease progression. Efficacy was based on local investigator assessment per international workshop on Chronic Lymphocytic Leukemia (iwCLL).
    End point type
    Secondary
    End point timeframe
    From baseline up to 157 days after last dose
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    0 [7]
    0 [8]
    1
    0 [9]
    0 [10]
    Units: Participants
        Progressive disease
    1
    Notes
    [7] - no CLL participants in this arm
    [8] - no CLL participants in this arm
    [9] - no CLL participants in this arm
    [10] - no CLL participants in this arm
    No statistical analyses for this end point

    Secondary: Best overall response (BOR) in NHL participants

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    End point title
    		 Best overall response (BOR) in NHL participants
    End point description
    The best overall response (BOR) is the best response recorded in a patient from the start of treatment until disease progression. Efficacy was based on local investigator assessment per Lugano criteria.
    End point type
    Secondary
    End point timeframe
    From baseline up to 157 days after last dose
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    4
    7
    6
    Units: Participants
        Complete Response (CR)
    0
    0
    0
    0
    1
        Partial Response (PR)
    0
    0
    0
    3
    1
        Stable Disease
    0
    0
    1
    0
    0
        Progressive Disease
    3
    3
    3
    4
    3
        Unkown
    1
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Overall response rate (ORR) in NHL participants

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    End point title
    		 Overall response rate (ORR) in NHL participants
    End point description
    The overall response rate (ORR), defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR). Efficacy was based on local investigator assessment per Lugano criteria.
    End point type
    Secondary
    End point timeframe
    From baseline up to 157 days after last dose
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    4
    7
    6
    Units: Participants
    0
    0
    0
    3
    2
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) in NHL participants

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    End point title
    		 Duration of Response (DOR) in NHL participants
    End point description
    The time between the date of first documented response (CR or PR) and the date of first documented progression or death due to underlying cancer. Duration of response was to be estimated using the Kaplan-Meier method. Efficacy was based on local investigator assessment per Lugano criteria. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    From baseline up to 157 days after last dose
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    3 [14]
    2 [15]
    Units: Months
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    999 ( 999 )
    999 ( 999 )
    Notes
    [11] - No participants with documented response in this arm
    [12] - No participants with documented response in this arm
    [13] - No participants with documented response in this arm
    [14] - NA: Not estimable due to insufficient number of participants with events
    [15] - NA: Not estimable due to insufficient number of participants with events
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) parameter AUClast JBH492 total antibody and JBH492 total ADC

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    End point title
    		 Pharmacokinetics (PK) parameter AUClast JBH492 total antibody and JBH492 total ADC
    End point description
    The area under the concentration-time curve (AUC) of JBH492 from time zero to the last measurable concentration sampling time (tlast) for total antibody and total antibody-drug-conjugate based on serum concentrations. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: hours * ug/mL
    geometric mean (geometric coefficient of variation)
        JBH492 total antibody (cycle 1) n=4,3,5,7,6
    1080 ( 57.6 )
    1460 ( 18.0 )
    4450 ( 36.4 )
    9330 ( 35.6 )
    9300 ( 99.6 )
        JBH492 total antibody (cycle 3) n=2,0,3,5,2
    1320 ( 0.8 )
    999 ( 999 )
    3290 ( 255.2 )
    17600 ( 31.8 )
    20600 ( 38.3 )
        JBH492 total ADC (cycle 1) n=4,3,5,7,6
    598 ( 38.7 )
    822 ( 41.1 )
    2280 ( 18.1 )
    5590 ( 29.0 )
    6030 ( 53.6 )
        JBH492 total ADC (cycle 3) n=2,0,3,5,2
    434 ( 20.4 )
    999 ( 999 )
    1440 ( 61.9 )
    5630 ( 21.5 )
    7090 ( 28.0 )
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) in NHL participants

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    End point title
    		 Progression Free Survival (PFS) in NHL participants
    End point description
    PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Efficacy was based on local investigator assessment per Lugano criteria. Participants were summarized into two pooled groups low dose and high dose cohorts.
    End point type
    Secondary
    End point timeframe
    From baseline up to 157 days after last dose
    End point values
    		 Low dose JBH492 0.4/0.8/1.6 mg/kg High dose JBH492 2.4/3.6 mg/kg
    Number of subjects analysed
    11
    13
    Units: Months
        median (inter-quartile range (Q1-Q3))
    1.0 (0.7 to 1.9)
    2.1 (2.1 to 8.9)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) parameter AUClast DM4 and sDM4

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    End point title
    		 Pharmacokinetics (PK) parameter AUClast DM4 and sDM4
    End point description
    The area under the concentration-time curve (AUC) of JBH492 from time zero to the last measurable concentration sampling time (tlast) for DM4 and sDM4 based on plasma concentrations. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: hour*ng/mL
    geometric mean (geometric coefficient of variation)
        DM4 (cycle 1) n=4,3,5,7,6
    4.86 ( 195.2 )
    14.6 ( 35.8 )
    77.9 ( 23.1 )
    142 ( 23.6 )
    177 ( 48.2 )
        DM4 (cycle 3) n=2,0,3,5,2
    11.8 ( 5.8 )
    999 ( 999 )
    47.2 ( 30.3 )
    231 ( 41.3 )
    248 ( 16.2 )
        sDM4 (cycle 1) n=4,3,5,7,6
    54.1 ( 15.4 )
    135 ( 32.1 )
    547 ( 43.9 )
    435 ( 52.4 )
    332 ( 348.2 )
        sDM4 (cycle 3) n=2,0,3,5,2
    154 ( 10.1 )
    999 ( 999 )
    522 ( 378.6 )
    784 ( 64.7 )
    562 ( 86.1 )
    No statistical analyses for this end point

    Secondary: PK parameter AUCinf JBH492 total antibody and JBH492 total ADC

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    End point title
    		 PK parameter AUCinf JBH492 total antibody and JBH492 total ADC
    End point description
    The AUC from time zero to infinity (mass × time × volume-1) for total antibody and total antibody-drug-conjugate based on serum concentrations of JBH492 total antibody and JBH492 total ADC. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    5
    Units: hour*ug/mL
    geometric mean (geometric coefficient of variation)
        JBH942 total antibody n=1,0,2,0,1
    489 ( 999 )
    999 ( 999 )
    3700 ( 66.2 )
    999 ( 999 )
    17500 ( 999 )
        JBH942 total ADC n=4,3,5,7,5
    643 ( 36.1 )
    900 ( 32.9 )
    2380 ( 17.6 )
    5900 ( 29.9 )
    7660 ( 19.8 )
    No statistical analyses for this end point

    Secondary: PK parameter AUCinf DM4 and sDM4

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    End point title
    		 PK parameter AUCinf DM4 and sDM4
    End point description
    The AUC from time zero to infinity (mass × time × volume-1) for DM4 and sDM4 based on plasma concentrations of DM4 and sDM4. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    0 [16]
    0 [17]
    2
    5
    4
    Units: hour*ng/mL
    geometric mean (geometric coefficient of variation)
        DM4 n=0,0,1,5,4
    ( )
    ( )
    99.4 ( 999 )
    158 ( 19.7 )
    226 ( 25.0 )
        sDM4 n=0,0,2,0,2
    ( )
    ( )
    614 ( 17.1 )
    999 ( 99 )
    601 ( 70.6 )
    Notes
    [16] - no participants with an available value for this endpoint
    [17] - no participants with an available value for this endpoint
    No statistical analyses for this end point

    Secondary: PK parameter AUCtau JBH492 total antibody and JBH492 total ADC

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    End point title
    		 PK parameter AUCtau JBH492 total antibody and JBH492 total ADC
    End point description
    The AUC calculated to the end of a dosing interval (tau) (mass × time × volume-1) for total antibody and total antibody-drug-conjugate based on serum concentrations of JBH492 total antibody and JBH492 total ADC. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 3. One cycle=21 days
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    1
    0 [18]
    1
    5
    2
    Units: hour*ug/mL
    geometric mean (geometric coefficient of variation)
        JBH492 total antibody n=0,0,0,0,0
    999 ( 999 )
    ( )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        JBH492 total ADC n=1,0,1,5,2
    547 ( 999 )
    ( )
    2650 ( 999 )
    5730 ( 21.4 )
    7100 ( 28 )
    Notes
    [18] - No participants with available value for endpoint
    No statistical analyses for this end point

    Secondary: PK parameter AUCtau DM4 and sDM4

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    End point title
    		 PK parameter AUCtau DM4 and sDM4
    End point description
    The AUC calculated to the end of a dosing interval (tau) (mass × time × volume-1) for four DM4 and sDM4 based on plasma concentrations of DM4 and sDM4. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 3. One cycle=21 days
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    5
    2
    Units: hour*ng/mL
    geometric mean (geometric coefficient of variation)
        DM4
    ( )
    ( )
    ( )
    239 ( 40.3 )
    248 ( 16.2 )
        sDM4
    ( )
    ( )
    ( )
    1100 ( 76.9 )
    563 ( 86.1 )
    Notes
    [19] - no participants with an available value for this endpoint
    [20] - no participants with an available value for this endpoint
    [21] - no participants with an available value for this endpoint
    No statistical analyses for this end point

    Secondary: PK parameter Cmax JBH492 total antibody and JBH492 total ADC

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    End point title
    		 PK parameter Cmax JBH492 total antibody and JBH492 total ADC
    End point description
    The maximum (peak)observed serum drug concentration (mass × volume-1) for total antibody and total antibody-drug-conjugate based on serum concentrations of JBH492 total antibody and JBH492 total ADC. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        JBH492 total antibody (Cycle 1)
    6.26 ( 38.4 )
    10.5 ( 41.0 )
    27.6 ( 23.0 )
    44.7 ( 14.1 )
    56.1 ( 19.0 )
        JBH492 total antibody (Cycle 3) n=2,0,3,5,2
    6.8 ( 28.2 )
    999 ( 999 )
    30.3 ( 17.6 )
    71.7 ( 14.3 )
    65.2 ( 49.5 )
        JBH492 total ADC (Cycle 1)
    7.03 ( 30.9 )
    7.81 ( 74.2 )
    27.2 ( 11.5 )
    49.4 ( 17.5 )
    66.4 ( 22.0 )
        JBH492 total ADC (Cycle 3) n=2,0,3,5,2
    5.11 ( 37.8 )
    999 ( 999 )
    24.8 ( 19.4 )
    53.8 ( 15.3 )
    53.2 ( 17.6 )
    No statistical analyses for this end point

    Secondary: PK parameter Cmax DM4 and sDM4

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    End point title
    		 PK parameter Cmax DM4 and sDM4
    End point description
    The maximum (peak)observed serum drug concentration (mass × volume-1) for DM4 and sDM4 based on plasma concentrations of DM4 and sDM4. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        DM4 (Cycle 1)
    0.316 ( 28.1 )
    0.571 ( 1.2 )
    1.24 ( 55.6 )
    2.07 ( 19.6 )
    2.48 ( 42.7 )
        DM4 (Cycle 3) n=2,0,3,5,2
    0.305 ( 6.7 )
    999 ( 999 )
    2.05 ( 238.8 )
    4.91 ( 320.2 )
    2.43 ( 37.2 )
        sDM4 (Cycle 1)
    0.196 ( 26.1 )
    0.567 ( 25.0 )
    2.01 ( 24.9 )
    1.64 ( 53.9 )
    2.19 ( 55.6 )
        sDM4 (Cycle 3) n=2,0,3,5,2
    0.522 ( 9.4 )
    999 ( 999 )
    4.62 ( 70.0 )
    3.32 ( 65.9 )
    2.46 ( 84.7 )
    No statistical analyses for this end point

    Secondary: PK parameter Tmax JBH492 total antibody and JBH492 total ADC

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    End point title
    		 PK parameter Tmax JBH492 total antibody and JBH492 total ADC
    End point description
    The time to reach maximum (peak) drug concentration (time) for total antibody and total antibody-drug-conjugate based on serum concentrations of JBH492 total antibody and JBH492 total ADC. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: hours
    median (full range (min-max))
        JBH492 total antibody (Cycle 1)
    13.2 (1.07 to 25.1)
    3.9 (1.92 to 71)
    1.07 (1 to 5.12)
    2.05 (1 to 2.12)
    2.95 (1 to 5)
        JBH492 total antibody (Cycle 3) n=2,0,3,5,2
    86 (4.88 to 167)
    999 (999 to 999)
    3.92 (1.17 to 4)
    2 (1.05 to 2.48)
    11.6 (1 to 22.2)
        JBH492 total ADC (Cycle 1)
    2.12 (1.07 to 24.3)
    2.03 (1.92 to 3.9)
    4.08 (1.02 to 5.12)
    2.08 (1 to 5.17)
    4.05 (1.05 to 25)
        JBH492 total ADC (Cycle 3) n=2,0,3,5,2
    25.4 (2.08 to 48.6)
    999 (999 to 999)
    3.92 (1.17 to 4)
    2.48 (1.08 to 5.08)
    1.96 (1 to 2.92)
    No statistical analyses for this end point

    Secondary: PK parameter Tmax DM4 and sDM4

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    End point title
    		 PK parameter Tmax DM4 and sDM4
    End point description
    The time to reach maximum (peak) drug concentration (time) for DM4 and sDM4 based on splasma concentrations of DM4 and sDM4. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: hours
    median (full range (min-max))
        DM4 (Cycle 1)
    2.08 (1.07 to 5.1)
    2.03 (1.92 to 3.9)
    1.18 (1.02 to 5.12)
    2.05 (1 to 25)
    1.18 (1 to 5.08)
        DM4 (Cycle 3) n=2,0,3,5,2
    2.08 (2.08 to 2.08)
    999 (999 to 999)
    1 (1 to 1.17)
    2 (1.05 to 2.48)
    11.6 (1 to 22.2)
        sDM4 (Cycle 1)
    281 (0 to 499)
    163 (70.8 to 329)
    71.8 (71.1 to 167)
    72 (50.8 to 168)
    37 (23.1 to 71.7)
        sDM4 (Cycle 3) n=2,0,3,5,2
    167 (166 to 167)
    999 (999 to 999)
    47.1 (46.4 to 47.7)
    49 (22.1 to 71)
    59.5 (46.5 to 72.5)
    No statistical analyses for this end point

    Secondary: PK parameter T1/2 JBH492 total antibody and JBH492 total ADC

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    End point title
    		 PK parameter T1/2 JBH492 total antibody and JBH492 total ADC
    End point description
    The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time) for total antibody and total antibody-drug-conjugate based on serum concentrations of JBH492 total antibody and JBH492 total ADC. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: hours
    geometric mean (geometric coefficient of variation)
        JBH492 total antibody (cycle1) n=1,0,2,0,1
    39 ( 999 )
    999 ( 999 )
    91.4 ( 53.6 )
    999 ( 999 )
    214 ( 999 )
        JBH492 total ADC (cycle 1) n=4,3,5,7,6
    84.8 ( 115.1 )
    87.9 ( 33.7 )
    89.3 ( 50.7 )
    109 ( 17.2 )
    117 ( 21.4 )
        JBH492 total ADC (cycle 3) n=1,0,1,5,2
    150 ( 999 )
    999 ( 999 )
    80.1 ( 999 )
    145 ( 45.5 )
    164 ( 20.2 )
    No statistical analyses for this end point

    Secondary: PK parameter T1/2 DM4 and sDM4

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    End point title
    		 PK parameter T1/2 DM4 and sDM4
    End point description
    The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time) for DM4 and sDM4 based on plasma concentrations of DM4 and sDM4. Due to EudraCT system limitations, data fields in the table cannot contain letters (eg. NA indicating ‘not applicable’). Therefore, not applicable values are indicated as ‘999’.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 4, 24, 48, 72, 168, 336 and 504 hours post-dose on Day 1 of Cycle 1 and Cycle 3. One cycle=21 days.
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    0 [22]
    0 [23]
    2
    5
    4
    Units: hours
    geometric mean (geometric coefficient of variation)
        DM4 (cycle 1) n=0,0,1,5,4
    ( )
    ( )
    69.7 ( 999 )
    75 ( 25.5 )
    104 ( 12.6 )
        DM4 (cycle 3) n=0,0,0,5,2
    ( )
    ( )
    999 ( 999 )
    142 ( 25.7 )
    158 ( 12.4 )
        sDM4 (cycle 1) n=0,0,2,0,2
    ( )
    ( )
    173 ( 6.1 )
    999 ( 999 )
    165 ( 9.1 )
        sDM4 (cycle 3) n=0,0,0,2,2
    ( )
    ( )
    999 ( 999 )
    181 ( 3.9 )
    197 ( 7.3 )
    Notes
    [22] - no participants with an available value for this endpoint
    [23] - no participants with an available value for this endpoint
    No statistical analyses for this end point

    Secondary: Incidence of anti-JBH492 antibodies

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    End point title
    		 Incidence of anti-JBH492 antibodies
    End point description
    Number of subjects with anti-JBH492 antibodies (Anti-Drug Antibodies)
    End point type
    Secondary
    End point timeframe
    From baseline until last dose os study treatment up to approximately 1.5 years
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    5
    Units: participants
        ADA positive at baseline
    0
    0
    2
    1
    0
        ADA positive with study treatment
    0
    1
    3
    2
    1
    No statistical analyses for this end point

    Post-hoc: All collected deaths

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    End point title
    		 All collected deaths
    End point description
    On-treatment and post-treatment safety follow-up (FU) deaths were collected from first dose of study treatment to 157 days after last dose. Survival FU deaths were collected from 157 days after last dose until end of study. All deaths refer to the sum of pre-treatment deaths, on-treatment and post-treatment safety FU deaths, and survival FU deaths.
    End point type
    Post-hoc
    End point timeframe
    From first dose of study treatment up to over 157 days after last treatment On-treatment and post-treatment safety FU deaths: up to approximately 1.6 years . Survival FU deaths: up to approximately 1.9 years
    End point values
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6mg/kg JBH492 2.4mg/kg JHB492 3.6mg/kg
    Number of subjects analysed
    4
    3
    5
    7
    6
    Units: participants
        On-treatment and post-treatment safety FU deaths
    1
    1
    0
    3
    3
        Survival FU deaths
    0
    0
    0
    0
    1
        All deaths
    1
    1
    0
    3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events: from first dose of study treatment until 157 days after last treatment up to maximum duration of 1.6 years Deaths: from first dose of study treatment until 157 days after last treatment up to maximum duration of 1.6 years
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    JBH492 0.4 mg/kg
    Reporting group description
    		 JBH492 0.4 mg/kg

    Reporting group title
    JBH492 0.8 mg/kg
    Reporting group description
    		 JBH492 0.8 mg/kg

    Reporting group title
    JBH492 1.6 mg/kg
    Reporting group description
    		 JBH492 1.6 mg/kg

    Reporting group title
    JBH492 2.4 mg/kg
    Reporting group description
    		 JBH492 2.4 mg/kg

    Reporting group title
    JBH492 3.6 mg/kg
    Reporting group description
    		 JBH492 3.6 mg/kg

    Reporting group title
    All Subjects
    Reporting group description
    		 All Subjects

    Serious adverse events
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6 mg/kg JBH492 2.4 mg/kg JBH492 3.6 mg/kg All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    4 / 6 (66.67%)
    8 / 25 (32.00%)
         number of deaths (all causes)
    1
    1
    0
    3
    3
    8
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Extravasation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 JBH492 0.4 mg/kg JBH492 0.8 mg/kg JBH492 1.6 mg/kg JBH492 2.4 mg/kg JBH492 3.6 mg/kg All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    7 / 7 (100.00%)
    5 / 6 (83.33%)
    24 / 25 (96.00%)
    Vascular disorders
    Venous thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    General disorders and administration site conditions
    Generalised oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Extravasation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    0
    0
    1
    0
    3
    Face oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    3 / 25 (12.00%)
         occurrences all number
    0
    0
    0
    2
    1
    3
    Mucosal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    4 / 25 (16.00%)
         occurrences all number
    0
    2
    1
    1
    0
    4
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Oedema genital
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Scrotal oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 3 (66.67%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    0
    0
    1
    2
    Organising pneumonia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Stridor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    7 / 25 (28.00%)
         occurrences all number
    0
    0
    3
    4
    4
    11
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Amylase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    2 / 7 (28.57%)
    3 / 6 (50.00%)
    7 / 25 (28.00%)
         occurrences all number
    0
    0
    2
    4
    4
    10
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    3 / 25 (12.00%)
         occurrences all number
    0
    0
    1
    1
    1
    3
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Blood potassium decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    5 / 25 (20.00%)
         occurrences all number
    1
    0
    2
    1
    1
    5
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    1
    0
    2
    3
    Lipase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    6
    0
    6
    Injury, poisoning and procedural complications
    Keratorhexis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    1 / 7 (14.29%)
    2 / 6 (33.33%)
    8 / 25 (32.00%)
         occurrences all number
    1
    1
    3
    1
    2
    8
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
    6 / 25 (24.00%)
         occurrences all number
    0
    2
    3
    2
    6
    13
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    4 / 25 (16.00%)
         occurrences all number
    0
    1
    2
    0
    1
    4
    Leukopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    2
    1
    0
    3
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Eye disorders
    Scleritis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Punctate keratitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    3 / 25 (12.00%)
         occurrences all number
    1
    0
    0
    0
    2
    3
    Dry eye
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    2 / 6 (33.33%)
    5 / 25 (20.00%)
         occurrences all number
    1
    0
    0
    2
    2
    5
    Corneal epithelial microcysts
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Visual acuity reduced
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    3 / 25 (12.00%)
         occurrences all number
    0
    0
    1
    1
    1
    3
    Mouth ulceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    1
    1
    0
    2
    Eczema
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    2 / 6 (33.33%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    0
    0
    3
    3
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 7 (28.57%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    3
    0
    3
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Ketosis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    2 / 25 (8.00%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jan 2020
    Incorporated health authority feedback • Inclusion criteria updated to specify histologic subtypes of NHL permitted in the dose escalation part • Clarified inclusion criteria related to enrollment of patients with r/r CLL, r/r NHL, indolent lymphoma, Richter’s transformation, and prior CAR-T therapy • Added recommendation for premedication to prevent IRRs in subsequent participants if early cohort participants experienced IRRs • Specified that in participants with grade 1 IRR, infusion rate to be decreased by 50% until recovery of symptoms to baseline • Added recommendations for the management of grade 2 and grade 3 IRRs and grade 3 and grade 4 tumor lysis syndrome • Definition of DLT updated; grade 4 hemolytic anemia, grade 4 thrombocytopenia, grade 3 skin rash, grade 2 pneumonitis, and grade 3 motor and/or sensory neuropathy were added as DLTs
    01 Aug 2020
    Incorporated health authority feedback • Clarified inclusion criteria related to relapsed or refractory disease, i.e., patients should have received and failed prior standard of care therapies and be intolerant or ineligible to approved therapies (conditions specified for CLL, NHL, and indolent lymphomas) • Inclusion criterion updated to add additional approved chemotherapeutics • Added ≥CTCAE grade 3 cytokine release syndrome as DLT • Added possibility of hospitalization up to 48 hours at Cycle 1 Day 1 in the dose escalation part, if required by health authority, to the Safety and tolerability section
    30 Nov 2021
    Updated exclusion criteria to allow patients with rapidly progressing NHL to be enrolled without unnecessary delay • Added exclusion criterion: patients who received any live vaccine against infectious diseases within 4 weeks prior to first dose of study treatment were not eligible • Added public health emergency mitigation procedures per updated regulation • Updated schedule of assessments to align with the section on ocular assessments where ophthalmologic exams during safety follow-up period if abnormal findings observed at EOT were included • For Japan only, change based on IB safety data: updated Japan hospitalization requirement from all of Cycle 1 to through C1D8 and included language for a longer stay based on general status of the participant • Updated schedule of assessments to clarify that lumbar puncture and CSF cytology were required at screening only for patients with CNS involvement or signs/symptoms of CNS involvement to reduce the burden of assessments for patients without CNS involvement • Specified that analysis of CCR7 expression may be performed on tumor material submitted from screen failure patients to utilize all samples collected in the escalation part, given that patient populations from the study selected indications are challenging to find • Aligned breastfeeding information with the IB: breast-feeding should not be performed while on study treatment, and for 180 days after discontinuation of JBH492 plus 60 days or five half-lives (whichever is longer) • Assessment of the benefit/risk concluded the absence of additional risks related to Covid-19 • Added physical exam for efficacy evaluations for NHL participants; physical exam would focus on assessment of constitutional symptoms as well as investigation of skin lesions • Multiple local clinical laboratory parameters were removed from collection because they are no longer required • Added HBV DNA to viral serology in local clinical laboratory parameters

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    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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