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    Clinical Trial Results:
    A Phase I-IIa trial to assess the safety and antitumor activity of autologous CD44v6 CAR T-cells in acute myeloid leukemia and multiple myeloma expressing CD44v6.

    Summary
    EudraCT number
    		 2018-000813-19
    Trial protocol
    		 CZ   IT  
    Global end of trial date
    18 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EURE-CART-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AGC Biologics S.p.A.
    Sponsor organisation address
    Via Meucci, 3 , Bresso (Milan), Italy, 20091
    Public contact
    Anna Stornaiuolo, AGC Biologics S.p.A., 0039 0221277440, astornaiuolo@agcbio.com
    Scientific contact
    Anna Stornaiuolo, AGC Biologics S.p.A., 0039 0221277440, astornaiuolo@agcbio.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
    07 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objectives of Phase I 1. To determine the maximum tolerated dose (MTD) and recommended phase IIa dose of MLMCAR44.1 T-cells in patients with relapsed/refractory acute myeloid leukemia (AML) or multiple myeloma (MM) expressing CD44v6. 2. To evaluate the overall safety of treatment with MLM-CAR44.1 T-cells. 3. To monitor for the absence of replication-competent retrovirus (RCR) Primary objective of phase IIa To evaluate hematological response to MLM-CAR44.1 T-cells in AML and MM.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The study was performed in compliance with Good Clinical Practices (CPMP/ICH/135/95), and the essential documents are archived as required by the applicable regulatory requirements. The study and any amendments were reviewed by an Independent Ethics Committees or Institutional Review Boards.
    Background therapy
    		 All patients were pre-treated with Proteasome inhibitor, high-dose alkylating agent, IMID, monoclonal antibodies from 2 up to 3 lines of treatment.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    7
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The multicenter study was conducted at 3 Institutions: -Coordinating Center: Haematology and Bone Marrow Transplant Unit, Ospedale San Raffaele, Milan, Italy; -Paediatric Haematology and Oncology Unit, Ospedale Pediatrico Bambino Gesù, Rome, Italy; -Department of Haematooncology, Fakultni Nemocnice, Czech Republic.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 8
    Number of subjects completed
    		 8

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

    Arms
    Arm title
    		 MLM-CAR44.1 T-cells Infusion
    Arm description
    		 Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 The dose of iv infused MLM-CAR44.1 T-cells is: PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLMCAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    MLM-CAR44.1 T-cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLMCAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).

    Number of subjects in period 1
    		MLM-CAR44.1 T-cells Infusion
    Started
    8
    Completed
    2
    Not completed
    6
         Disease progression
    1
         Screening failures
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (41 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 6 6
    Race (NIH/OMB)
    Units: Subjects
        White
    		 8 8
    Region of Enrollment
    Units: Subjects
        Italy
    		 5 5
        Czechia
    		 3 3
    Confirmed diagnosis of MM
    Units: Subjects
        Confirmed diagnosis of MM
    		 8 8
    Patients with relapse or refractory disease
    Units: Subjects
        Patients with relapse or refractory disease
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    MLM-CAR44.1 T-cells Infusion
    Reporting group description
    		 Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 The dose of iv infused MLM-CAR44.1 T-cells is: PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLMCAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).

    Primary: Phase I: Maximum Tolerated Dose (MTD) and the Recommended Phase IIa Dose of MLM-CAR44.1 T-cells in AML and MM

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    End point title
    		 Phase I: Maximum Tolerated Dose (MTD) and the Recommended Phase IIa Dose of MLM-CAR44.1 T-cells in AML and MM [1]
    End point description
    MTD established through BOIN design and the dose-limiting toxicities (DLTs) occurring following CAR T-cell infusion.
    End point type
    Primary
    End point timeframe
    Within 30 days following CAR T-cell infusion, assessed as day 0
    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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [2]
    Units: Overall Number of Participants Analyzed
    Notes
    [2] - Data were not collected due to early end of trial
    No statistical analyses for this end point

    Primary: Phase I: Overall Safety of Treatment With MLM-CAR44.1 T-cells

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    End point title
    		 Phase I: Overall Safety of Treatment With MLM-CAR44.1 T-cells [3]
    End point description
    Safety will be evaluated by analyzing the type, frequency and severity of adverse events (AE) and by monitoring for systemic reactions (fever, tachycardia, nausea and vomiting, joint pain, skin rash). Overall, 3 study emergent serious adverse events (SAEs) were reported in patients treated with MLM-CAR44.1 T-cells.
    End point type
    Primary
    End point timeframe
    For 30 days following CAR T-cell infusion, assessed as day 0.
    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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2
    Units: Number of SAEs
    3
    No statistical analyses for this end point

    Primary: Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 3 Months Post-infusion

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    End point title
    		 Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 3 Months Post-infusion [4]
    End point description
    The absence of replication competent retrovirus (RCR) in blood specimens: 3 months post-infusion will be monitored by DNA PCR for the Galv gene. RCR search was conducted centrally using a quantitative molecular test, (real time quantitative PCR, q-PCR analysis) determining the absence of RCR by DNA PCR for the Galv and gag-pol genes on genomic DNA from patient’s peripheral blood lymphocytes. The objective of this q-PCR analysis is to exclude the presence of RCR originated by recombination with PG13 packaging cell sequences by detecting the Galv and gag-pol transcripts in the transduced cells. The absence of the Galv and gag-pol transcripts can exclude the presence of an RCR, while its presence is not sufficient to indicate the presence of an RCR, and in this case further analysis is required.
    End point type
    Primary
    End point timeframe
    3 months after infusion (assessed as day 0)
    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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2
    Units: Count of Participants
    2
    No statistical analyses for this end point

    Primary: Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 6 Months Post-infusion

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    End point title
    		 Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 6 Months Post-infusion [5]
    End point description
    The absence of replication competent retrovirus (RCR) in blood specimens will be monitored by DNA PCR for the Galv gene. RCR search was conducted centrally using a quantitative molecular test, (real time quantitative PCR, q-PCR analysis) determining the absence of RCR by DNA PCR for the Galv and gag-pol genes on genomic DNA from patient’s peripheral blood lymphocytes. The objective of this q-PCR analysis is to exclude the presence of RCR originated by recombination with PG13 packaging cell sequences by detecting the Galv and gag-pol transcripts in the transduced cells. The absence of the Galv and gag-pol transcripts can exclude the presence of an RCR, while its presence is not sufficient to indicate the presence of an RCR, and in this case further analysis is required
    End point type
    Primary
    End point timeframe
    6 months after infusion (assessed as day 0)
    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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2
    Units: Count of Participants
    2
    No statistical analyses for this end point

    Primary: Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 12 Months Post-infusion

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    End point title
    		 Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 12 Months Post-infusion [6]
    End point description
    The absence of replication competent retrovirus (RCR) in blood specimens will be monitored by DNA PCR for the Galv gene.
    End point type
    Primary
    End point timeframe
    12 months after infusion (assessed as day 0)
    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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [7]
    Units: Overall Number of Participants Analyzed
    Notes
    [7] - Data were not collected due to early end of trial
    No statistical analyses for this end point

    Primary: Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 24 Months Post-infusion

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    End point title
    		 Phase I: Absence of Replication Competent Retrovirus (RCR) in Blood Specimens: 24 Months Post-infusion [8]
    End point description
    The absence of replication competent retrovirus (RCR) in blood specimens will be monitored by DNA PCR for the Galv gene
    End point type
    Primary
    End point timeframe
    24 months after infusion (assessed as day 0)
    Notes
    [8] - 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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [9]
    Units: Overall Number of Participants Analyzed
    Notes
    [9] - Data were not collected due to early end of trial
    No statistical analyses for this end point

    Primary: Phase IIa: Hematological Disease Response to MLM-CAR44.1 T-cells in AML

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    End point title
    		 Phase IIa: Hematological Disease Response to MLM-CAR44.1 T-cells in AML [10]
    End point description
    The hematologic disease response will be classified according to ELN criteria
    End point type
    Primary
    End point timeframe
    2 months after MLM-CAR44.1 T-cell infusion, assessed as day 0
    Notes
    [10] - 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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [11]
    Units: Overall Number of Participants Analyzed
    Notes
    [11] - Data were not collected because Phase IIa was not performed due to early end of trial
    No statistical analyses for this end point

    Primary: Phase IIa: Hematological Disease Response to MLM-CAR44.1 T-cells in MM

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    End point title
    		 Phase IIa: Hematological Disease Response to MLM-CAR44.1 T-cells in MM [12]
    End point description
    The hematologic disease response will be classified according to IMWG criteria
    End point type
    Primary
    End point timeframe
    3 months after T-cell infusion, assessed as day 0
    Notes
    [12] - 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: Due to the low number of enrolled and treated patients no statistical analysis were performed.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2 [13]
    Units: Count of Participants
    0
    Notes
    [13] - Data were not collected because Phase IIa was not performed due to early end of trial
    No statistical analyses for this end point

    Secondary: Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in AML

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    End point title
    		 Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in AML
    End point description
    The hematologic disease response will be classified with the following response criteria: complete response (CR), incomplete response (CRi) and partial response (PR) according to ELN criteria.
    End point type
    Secondary
    End point timeframe
    1 and 2 months following T-cell infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [14]
    Units: Overall Number of Participants Analyzed
    Notes
    [14] - Data were not collected because no AML patients were enrolled
    No statistical analyses for this end point

    Secondary: Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in MM

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    End point title
    		 Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in MM
    End point description
    Hematologic disease response evaluated at Day 28 following CART-cell infusion, as overall response rate (ORR), stringent complete response (sCR), CR, very good partial response (VGPR) and partial response (PR).
    End point type
    Secondary
    End point timeframe
    1 and 3 months following T-cell infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2
    Units: Count of Participants
        No response detected
    2
        Hematologic disease response
    0
    No statistical analyses for this end point

    Secondary: Phase I: The Levels of Circulating MLM-CAR44.1 T-cells in Blood Samples

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    End point title
    		 Phase I: The Levels of Circulating MLM-CAR44.1 T-cells in Blood Samples
    End point description
    The levels will be evaluated by flow cytometry and qPCR (in vivo pharmacokinetic profile).
    End point type
    Secondary
    End point timeframe
    At day 7, 14, 21, 28, 60, 90, 180 from infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    2
    Units: Count of Participants
        Positive at day 14 and 21
    1
        Negative at all monitoring time points
    1
    No statistical analyses for this end point

    Secondary: Phase I: The Percentage of Patients for Whom Activation of Suicide Gene Was Needed

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    End point title
    		 Phase I: The Percentage of Patients for Whom Activation of Suicide Gene Was Needed
    End point description
    Suicide gene activation and elimination of transduced cells will be established through administration of ganciclovir in case of cytokine-release syndrome (CRS) and other MLM-CAR44.1 T-cell related toxicities.
    End point type
    Secondary
    End point timeframe
    At day 7, 14, 21, 28, 60, 90, 180 from infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [15]
    Units: Overall Number of Participants Analyzed
    Notes
    [15] - Data were not collected because no MLM-CAR44.1 T-cell related toxicities occurred
    No statistical analyses for this end point

    Secondary: Phase IIa: Hematologic Disease Response in AML

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    End point title
    		 Phase IIa: Hematologic Disease Response in AML
    End point description
    The hematologic disease response will be classified with the following response criteria: complete response (CR), incomplete response (CRi) and partial response (PR) according to ELN criteria.
    End point type
    Secondary
    End point timeframe
    1, 2 and 6 months after MLM-CAR44.1 T-cell infusion, assessed as day 0.
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [16]
    Units: Overall Number of Participants Analyzed
    Notes
    [16] - Data were not collected because Phase IIa was not performed due to early end of trial.
    No statistical analyses for this end point

    Secondary: Phase IIa: Hematologic Disease Response in MM

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    End point title
    		 Phase IIa: Hematologic Disease Response in MM
    End point description
    The hematologic disease response will be defined based on the overall response rate (ORR): stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to IMWG criteria
    End point type
    Secondary
    End point timeframe
    1, 2 and 6 months after T-cell infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [17]
    Units: Overall Number of Participants Analyzed
    Notes
    [17] - Data were not collected because Phase IIa was not performed due to early end of trial.
    No statistical analyses for this end point

    Secondary: Phase IIa: Overall Survival (OS)

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    End point title
    		 Phase IIa: Overall Survival (OS)
    End point description
    Overall Survival (OS) is defined as the time from the date of MLM-CAR44.1 T-cell infusion to the date of last follow-up or death due to any cause, whichever occurs first. One patients out of the 2 treated was still alive at the date of the early study termination. One patient died after EURE-CART-1 cell infusion, at day 121, for disease progression.
    End point type
    Secondary
    End point timeframe
    At the date of the early study termination
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [18]
    Units: Overall Number of Participants Analyzed
    Notes
    [18] - Data were not collected because Phase IIa was not performed due to early end of trial.
    No statistical analyses for this end point

    Secondary: Exploratory Outcome of Phase IIa: Percentages of Patients With Minimal Residual Disease

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    End point title
    		 Exploratory Outcome of Phase IIa: Percentages of Patients With Minimal Residual Disease
    End point description
    AML: proportion of patients with a molecular complete response (CR); MM: proportion of patients with a molecular CR.
    End point type
    Secondary
    End point timeframe
    AML: 2 months after infusion, assessed as day 0. MM: 3 months after infusion, assessed as day 0
    End point values
    		 MLM-CAR44.1 T-cells Infusion
    Number of subjects analysed
    0 [19]
    Units: Overall Number of Participants Analyzed
    Notes
    [19] - Data were not collected because Phase IIa was not performed due to early end of trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Assessed up to 15 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    MLM-CAR44.1 T-cells Infusion
    Reporting group description
    		 Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 The dose of iv infused MLM-CAR44.1 T-cells is: PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLMCAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).

    Serious adverse events
    		 MLM-CAR44.1 T-cells Infusion
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MLM-CAR44.1 T-cells Infusion
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2
    Immune system disorders
    Pyrexia
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2020
    Clinical Study Protocol, version C

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Jun 2021
    The early termination of this study is due to the analysis of its feasibility, based on the low patient recruitment rate (due to the lower-than-expected proportion of myeloma and leukemia expressing the CD44v6). A further decrease in the recruitment occurred with the diffusion of the COVID-19 emergency and the availability of new drugs for the treatment of myeloma and leukemia. These reasons make impossible to foresee the conclusion of the study in a clinically relevant time frame.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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