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    Clinical Trial Results:
    An exploratory, open-label, multicenter study to evaluate the safety and efficacy of ATIR, donor T-lymphocytes depleted ex vivo of host alloreactive T-cells, in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor

    Summary
    EudraCT number
    		 2012-004461-41
    Trial protocol
    		 BE   DE   GB  
    Global end of trial date
    19 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2021
    First version publication date
    07 Jan 2021
    Other versions
    Summary report(s)
    		 CSR CR-AIR-007 Report Synopsis FINAL Revised 18JUL2018

    Trial information

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    Trial identification
    Sponsor protocol code
    CR-AIR-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01794299
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kiadis Pharma Netherlands
    Sponsor organisation address
    Paasheuvelweg 25A, Amsterdam, Netherlands, 1105BP
    Public contact
    Senior Director Regulatory Affairs, Kiadis Pharma Netherlands B.V., +31 20 2405 277, l.gerez@kiadis.com
    Scientific contact
    Senior Director Regulatory Affairs, Kiadis Pharma Netherlands B.V., +31 20 2405 277, l.gerez@kiadis.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
    18 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the safety and efficacy of ATIR at a dose of 2x10E6 viable T-cells/kg body weight in patients with a hematologic malignancy who received a haploidentical HSCT.
    Protection of trial subjects
    Protocol and informed consent forms (ICFs) were reviewed and approved by appropriate Independent Ethics Committees (IECs). The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (and all amendments thereof) and that are consistent with the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (Topic E6 [R1]) as well as the applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    23
    EEA total number of subjects
    5
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this study all eligible patients were planned to be treated with a single dose of ATIR101.

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

    Arms
    Arm title
    		 ATIR101
    Arm description
    		 T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment (ATIR)
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATIR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received an ATIR101 dose of 2.0 × 106 viable T cells/kg at a median of 28 days (range 28–73) post HSCT.

    Number of subjects in period 1
    		ATIR101
    Started
    23
    Completed
    9
    Not completed
    14
         Adverse event, serious fatal
    13
         preferred to be treated in a hospital closer to ho
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ATIR101
    Reporting group description
    		 T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment (ATIR)

    Reporting group values
    		 ATIR101 Total
    Number of subjects
    		 23 23
    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)
    		 23 23
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    ATIR101
    Reporting group description
    		 T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment (ATIR)

    Primary: Transplant Related Mortality (TRM)

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    End point title
    		 Transplant Related Mortality (TRM) [1]
    End point description
    End point type
    Primary
    End point timeframe
    The TRM rate is displayed as a function of time using the Kaplan-Meier method. The TRM rate at 6 months post HSCT is estimated from this analysis.
    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: The primary endpoint is TRM until 6 months post HSCT. TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide). TRM is a common outcome measure for assessing the efficacy of HSCTs. The primary efficacy endpoint, TRM at 6 months post HSCT, is estimated to be 13% (95% CI 5-36%).
    End point values
    		 ATIR101
    Number of subjects analysed
    23
    Units: Percentage
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    ATIR101
    Reporting group description
    		 -

    Serious adverse events
    		 ATIR101
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 23 (13.04%)
         number of deaths (all causes)
    14
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    autoimmune hemolytic anemia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    acute GVHD
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    chronic GVHD
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ATIR101
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 23 (17.39%)
    Immune system disorders
    acute GVHD
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32047237
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    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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