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    Clinical Trial Results:
    An exploratory, open-label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor

    Summary
    EudraCT number
    		 2015-002821-20
    Trial protocol
    		 BE   DE   PT   HR  
    Global end of trial date
    17 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2021
    First version publication date
    02 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR-AIR-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02500550
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kiadis Pharma
    Sponsor organisation address
    Paasheuvelweg 25A, Amsterdam, Netherlands, 1105BP
    Public contact
    Clinical Trial Information, Kiadis Pharma Netherlands B.V., +31 203140250, clinicaltrials@kiadis.com
    Scientific contact
    Clinical Trial Information, Kiadis Pharma Netherlands B.V., +31 203140250, clinicaltrials@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
    25 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to study the safety and efficacy of a repeat dose administration of ATIR101 in patients with a hematologic malignancy who received a T-cell depleted haploidentical HSCT.
    Protection of trial subjects
    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. The investigator/sub-investigator was responsible for explaining the nature and purpose of the study as well as other study-related matters to patients and donors, using the written information, and for obtaining their full understanding and written consent to participate in the study at their own free will. No patient/donor was to be subjected to undue influence, such as compulsory enrollment into the study. Informed consent had to be obtained prior to performing the first observations/examinations of the screening period (use of assessments which were performed before signing informed consent was subject of informed consent).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2015
    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: 7
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).

    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
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATIR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The first four ATIR101-treated patients were infused with two doses of 2.0×10e6 viable T-cells/kg (based on the patient weight at screening). As decided in consultation with the IDMC, the next two patients were infused with a first dose 2.0×10e6 viable T-cells/kg and a second dose of 1.0×10e6 viable T-cells/kg. As recommended by the IDMC the remaining patients were infused with a single ATIR101 dose of 2.0×10e6 viable T-cells/kg. The first ATIR101 dose was infused at a median of 28.0 days (range 27-46) after the HSCT and the second ATIR101 dose (if given) was infused at a median of 73.5 days (range 71-77) after the HSCT.

    Number of subjects in period 1
    		ATIR101
    Started
    15
    Completed
    8
    Not completed
    7
         Adverse event, serious fatal
    7

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    ATIR101
    Reporting group description
    		 -

    Primary: incidence of grade III/IV acute GVHD up to 180 days after HSCT.

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    End point title
    		 incidence of grade III/IV acute GVHD up to 180 days after HSCT. [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint was the incidence of grade III/IV acute GVHD up to 180 days after HSCT. Therefore, the primary analysis was based on the data at 180 days after the HSCT.
    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: Overall in the study, four ATIR101-treated patients met the primary endpoint, grade III/IV acute GVHD within 180 days after HSCT: two (33.3%) in the double-dose group and two (22.2%) in the single-dose group
    End point values
    		 ATIR101
    Number of subjects analysed
    15
    Units: number of patients
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 1-year post HSCT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    ATIR101
    Reporting group description
    		 -

    Serious adverse events
    		 ATIR101
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 15 (46.67%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    7
    Immune system disorders
    cGVHD
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 7
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ATIR101
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 15 (53.33%)
    Investigations
    Cytomegalovirus test positive
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Immune system disorders
    aGVHD
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    7
    cGVHD
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2

    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
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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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