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    Clinical Trial Results:
    A prospective phase I/II study to investigate the feasibility, safety and efficacy of IL-15 activated cytokine induced killer (CIK) cells in relapsing patients with acute leukemia or myelodysplastic syndromes after allogeneic stem cell transplantation

    Summary
    EudraCT number
    		 2013-005446-11
    Trial protocol
    		 DE  
    Global end of trial date
    21 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2026
    First version publication date
    29 May 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FFM-CIK-CellStudy01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goethe-Universität Frankfurt
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt, Germany, 60590
    Public contact
    Division of Stem Cell Transplantation and Immunology, Department of Pediatrics, Goethe-University Frankfurt, eva.rettinger@icloud.com
    Scientific contact
    Division of Stem Cell Transplantation and Immunology, Department of Pediatrics, Goethe-University Frankfurt, eva.rettinger@icloud.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
    14 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and feasibility of increasing cell doses of CIK cell transfusions in adult and pediatric leukemia and MDS patients with molecular, cytogenetic or hematologic relapse after allogeneic SCT.
    Protection of trial subjects
    IL15-CIK infusions were administered at "safety" intervals of 4-6 weeks, without the use of preconditioning or lymphodepletion. The starting dose was 1.0 ×10⁶ CD3⁺CD56- cells/kg, with escalation to 5.0 ×10⁶, 1.0 ×10⁷, and up to 1.0 ×10⁸ cells/kg based on MRD status and absence of new or worsening aGvHD (to protect trial subjects).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2016
    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
    Germany: 17
    Worldwide total number of subjects
    17
    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)
    10
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    1
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible patients were children and adults (aged >1–<80 years) with HR hematological malignancies who had undergone HCT. Inclusion required relapse >120 days post-transplant, reappearance of MRD, cytogenetic abnormalities, or MC (mixed chimersim).

    Pre-assignment
    Screening details
    		 Eligible patients were children and adults (aged >1–<80 years) with HR hematological malignancies who had undergone HCT. Inclusion required relapse >120 days post-transplant, reappearance of MRD, cytogenetic abnormalities, or MC (mixed chimersim).

    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
    		 CIK intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CIK cells
    Investigational medicinal product code
    IL-15
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Starting dose of 1x106 CD3+CD56- CIK cells/kg recipient body weight will be increased in intervals of 4-6 weeks to 5x106 CD3+CD56-, and 1x107 CD3+CD56- CIK cells/kg. CIK cell dose may be increased to 5x107 CD3+CD56- CIK cells/kg and 1x108 CD3+CD56- CIK cells/kg in pediatric patients with HLA-matched CIK cell infusions and completed T cell reconstitution only, who remained without any signs of aGvHD after a minimum of four CIK cell treatments. Patients will be screened for relapse and signs of GvHD according to GSC. Patients who experience disease progression or < grade II aGvHD may receive modified CIK cell doses. No further CIK cell infusions will be administered in the presence of aGvHD ≥ grade II.

    Number of subjects in period 1
    		CIK intervention
    Started
    17
    Completed
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 17 17
    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)
    		 10 10
        Adolescents (12-17 years)
    		 2 2
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 8.3 (3.6 to 71.9) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 11 11
    Diagnosis
    Units: Subjects
        B-ALL
    		 5 5
        AML
    		 10 10
        CMML
    		 1 1
        MDS
    		 1 1
    Number of SCTs
    Units: Subjects
        One
    		 14 14
        Two
    		 3 3
    Remission before SCT
    Units: Subjects
        CR1
    		 8 8
        CR2
    		 5 5
        >CR2
    		 3 3
        NR
    		 1 1
    Donor
    Units: Subjects
        MSD
    		 1 1
        MUD
    		 12 12
        MMFD
    		 3 3
        MMUD
    		 1 1
    Stem cell source
    Units: Subjects
        BM
    		 9 9
        PBSC
    		 8 8
    T cell depletion (SCT)
    Units: Subjects
        No
    		 13 13
        Yes
    		 4 4
    Serotherapy
    Units: Subjects
        ATG
    		 11 11
        Campath
    		 5 5
        No serotharapy
    		 1 1
    Number of CIK cell administrations
    Units: Subjects
        One
    		 5 5
        Two
    		 4 4
        Three
    		 1 1
        Four
    		 4 4
        Five
    		 2 2
        Six
    		 0 0
        Seven
    		 0 0
        Eight
    		 1 1
    Age
    Units: year
        median (full range (min-max))
    		 8.3 (3.6 to 71.9) -
    CD34+ (SCT)
    Units: 10^6/kg
        median (full range (min-max))
    		 7.1 (1.7 to 40.0) -
    CD3+ (SCT)
    Units: 10^6/kg
        median (full range (min-max))
    		 24.9 (0.0 to 107.3) -
    ATG dose (SCT)
    Units: mg/kg
        median (full range (min-max))
    		 60.9 (27.7 to 83.6) -
    Campath dose (SCT)
    Units: mg/kg
        median (full range (min-max))
    		 1.3 (0.4 to 2.0) -
    Duration from SCT to first CIK infusion
    Units: month
        median (full range (min-max))
    		 6.2 (1.4 to 17.8) -
    Cumulative CIK cell dose
    Units: 10^6/kg
        median (full range (min-max))
    		 6.1 (1.0 to 190.7) -
    Maximum CIK cell dose
    Units: 10^6/kg
        median (full range (min-max))
    		 5.1 (1.0 to 100.0) -
    Subject analysis sets

    Subject analysis set title
    all subjects
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Full analysis set.

    Subject analysis sets values
    		 all subjects
    Number of subjects
    17
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    10
        Adolescents (12-17 years)
    2
        Adults (18-64 years)
    1
        From 65-84 years
    4
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    8.3 (3.6 to 71.9)
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    11
    Diagnosis
    Units: Subjects
        B-ALL
    5
        AML
    10
        CMML
    1
        MDS
    1
    Number of SCTs
    Units: Subjects
        One
    14
        Two
    3
    Remission before SCT
    Units: Subjects
        CR1
    8
        CR2
    5
        >CR2
    3
        NR
    1
    Donor
    Units: Subjects
        MSD
    1
        MUD
    12
        MMFD
    3
        MMUD
    1
    Stem cell source
    Units: Subjects
        BM
    9
        PBSC
    8
    T cell depletion (SCT)
    Units: Subjects
        No
    13
        Yes
    4
    Serotherapy
    Units: Subjects
        ATG
    11
        Campath
    5
        No serotharapy
    1
    Number of CIK cell administrations
    Units: Subjects
        One
    5
        Two
    4
        Three
    1
        Four
    4
        Five
    2
        Six
    0
        Seven
    0
        Eight
    1
    Age
    Units: year
        median (full range (min-max))
    8.3 (3.6 to 71.9)
    CD34+ (SCT)
    Units: 10^6/kg
        median (full range (min-max))
    7.1 (1.7 to 40.0)
    CD3+ (SCT)
    Units: 10^6/kg
        median (full range (min-max))
    24.9 (0.0 to 107.3)
    ATG dose (SCT)
    Units: mg/kg
        median (full range (min-max))
    60.9 (27.7 to 83.6)
    Campath dose (SCT)
    Units: mg/kg
        median (full range (min-max))
    1.3 (0.4 to 2.0)
    Duration from SCT to first CIK infusion
    Units: month
        median (full range (min-max))
    6.2 (1.4 to 17.8)
    Cumulative CIK cell dose
    Units: 10^6/kg
        median (full range (min-max))
    6.1 (1.0 to 190.7)
    Maximum CIK cell dose
    Units: 10^6/kg
        median (full range (min-max))
    5.1 (1.0 to 100.0)

    End points

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    End points reporting groups
    Reporting group title
    CIK intervention
    Reporting group description
    		 -

    Subject analysis set title
    all subjects
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Full analysis set.

    Primary: Grade III or IV aGvHD or extensive cGvHD

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    End point title
    		 Grade III or IV aGvHD or extensive cGvHD [1]
    End point description
    Incidence of Grade III or IV aGvHD or extensive cGvHD
    End point type
    Primary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    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: To assess dose-limiting toxicity the number of adverse events is too small (n=1).
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
    1
    1
    No statistical analyses for this end point

    Secondary: Toxicity - aGvHD

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    End point title
    		 Toxicity - aGvHD
    End point description
    Incidence and severity of aGvHD
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
        No aGvHD
    7
    7
        Grade 1 aGvHD
    5
    5
        Grade 2 aGvHD
    4
    4
        Grade 3 aGvHD
    1
    1
        Grade 4 aGvHD
    0
    0
    No statistical analyses for this end point

    Secondary: Toxicity - cGvHD

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    End point title
    		 Toxicity - cGvHD
    End point description
    Incidence and severity of cGvHD
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
        No cGvHD
    15
    15
        Limited cGvHD
    2
    2
        Extensive cGvHD
    0
    0
    No statistical analyses for this end point

    Secondary: Feasibility – manufactured batches

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    End point title
    		 Feasibility – manufactured batches
    End point description
    Number of successfully manufactured IL-15 CIK batches
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
        Manufacturing of IL-15 CIK batch successful
    17
    17
        Manufacturing of IL-15 CIK batch not successful
    0
    0
    No statistical analyses for this end point

    Secondary: Feasibility – Time from request to release

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    End point title
    		 Feasibility – Time from request to release
    End point description
    Time from request to release of IL-15 CIK batches
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    14
    14
    Units: day
        median (full range (min-max))
    20 (10 to 42)
    20 (10 to 42)
    No statistical analyses for this end point

    Secondary: Response

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    End point title
    		 Response
    End point description
    Response evaluated on day 100 after first IL-15 CIK infusion
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
        Complete molecular remission
    7
    7
        Complete remission
    7
    7
        Alive in relapse
    2
    2
        Death due to relapse
    0
    0
        NRM
    1
    1
    No statistical analyses for this end point

    Secondary: Tumor escape mechanisms

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    End point title
    		 Tumor escape mechanisms
    End point description
    Incidence of relapse before achieving a complete molecular remission and before suffering from NRM
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment to end of study
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: Subjects
        Relapse
    4
    4
    No statistical analyses for this end point

    Secondary: Overall Survival at 6 years

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    End point title
    		 Overall Survival at 6 years
    End point description
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment until, death, loss to follow-up or end of study.
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: percent
        number (confidence interval 95%)
    68.0 (38.4 to 85.6)
    68.0 (38.4 to 85.6)
    No statistical analyses for this end point

    Secondary: Progression free Survival at 6 years

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    End point title
    		 Progression free Survival at 6 years
    End point description
    Time to disease progression or death from any cause, whichever occurred first. Censoring at subsequent HSCT, loss to follow-up or end of study.
    End point type
    Secondary
    End point timeframe
    From start of IL-15 CIK treatment until progression, death, subsequent HSCT, loss to follow-up or end of study.
    End point values
    		 CIK intervention all subjects
    Number of subjects analysed
    17
    17
    Units: percent
        number (confidence interval 95%)
    56.6 (29.6 to 76.7)
    56.6 (29.6 to 76.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first treatment to 12 months after last CIK cell infusion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    1
    Respiratory, thoracic and mediastinal disorders
    Progressive lung infiltration
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    CMV reactivation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 all subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 17 (23.53%)
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Atopic eczema
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Osteomyelitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    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
    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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