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    Summary
    EudraCT Number:2018-000205-22
    Sponsor's Protocol Code Number:CYAD-N2T-005
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-000205-22
    A.3Full title of the trial
    An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after a non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplastic syndrome patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study aiming at investigating the potential safety of multiple administrations of NKR-2 after chemotherapy treatment targeting T-cells in patients with acute myeloid leukemia. The NKR-2 treatment is based on patient's own T-cells that will be collected and modified before being injected to generate anti-tumor responses.
    A.3.2Name or abbreviated title of the trial where available
    DEPLETHINK – LymphoDEPLEtion and THerapeutic Immunotherapy with NKR-2
    A.4.1Sponsor's protocol code numberCYAD-N2T-005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelyad Onclogy SA
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelyad Oncology SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelyad Oncology SA
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRue Edouard Belin 2
    B.5.3.2Town/ cityMont-Saint-Guibert
    B.5.3.3Post code1435
    B.5.3.4CountryBelgium
    B.5.4Telephone number3210394100
    B.5.5Fax number3210394141
    B.5.6E-mailinfo@celyad.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNKR-2
    D.3.2Product code NKR-2
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number Not applicab
    D.3.9.2Current sponsor codeNKR-2/DS
    D.3.9.3Other descriptive nameNKR-2/DS
    D.3.9.4EV Substance CodeSUB184197
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000000 to 3000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberGTMP (EMA/CAT/577818/2016)
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NKR-2 has the potential to treat many distinct tumor-types. This trial will focus on Relapsed and/or refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
    E.1.1.1Medical condition in easily understood language
    NKR-2 is indicated for the treatment of blood cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to document and characterized:
    Phase I: the safety of the NKR-2 treatment administration in r/r AML/MDS patients after a non-myeloablative preconditioning.
    Phase II: the clinical activity of the NKR-2 treatment administration in r/r AML/MDS patients after a non-myeloablative preconditionning
    E.2.2Secondary objectives of the trial
    The secondary objectives are to document and characterize:

    • The NKR-2 peripheral blood kinetics post-administration,
    • Indicators of clinical activity,
    • Additional indicators of safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men or women ≥ 18 and ≤ 75 years old at the time of signing the Informed Consent Form (ICF).
    2) The patient is not eligible for standard of care therapy and must have one of the following hematological malignancy:
    - A confirmed relapsed or refractory acute myeloid leukemia (AML) (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) after at least one prior therapy.
    - A confirmed myelodysplastic syndrome (MDS) with revised International Prognostic Scoring System (R-IPSS) criteria for Intermediate, High-risk or Very High-risk disease or refractory anemia with excess blasts by WHO (i.e. ≥ 5% blasts in bone marrow or ≥ 2% blasts in peripheral blood) or MDS with TP53 mutation as detected by next-generation sequencing (NGS).
    3) The absolute peripheral blast count should be < 15,000/µL.
    4) The patient must have an ECOG performance status ≤2.
    5) The patient must have sufficient hepatic and renal functions,.
    6) Ejection fraction of ≥ 40%.
    7)Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in the first second (FEV-1)/Forced Vital Capacity (FVC) ≥ 0.7 with FEV-1 ≥ 50% predicted.
    E.4Principal exclusion criteria
    1) Patient presenting with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease (COPD).
    2) Patient that received any cancer therapy within 2 weeks before the planned day for the apheresis (with the exception of hydroxyurea).
    3) Patients receive, concurrently receive, or have received any investigational agent within 3 weeks before the planned day for the first NKR-2 administration (except for hydroxyurea).
    4) Patient is under systemic immunosuppressive drugs, unless specific cases authorized per protocol.
    5) Patients have received prior allogeneic stem cell transplantation or chimeric antigen receptor therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: The occurrence of DLTs during the study treatment.
    Phase II: The objective response rate (ORR) post the first KKR-2 administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: During the administration phase, up to administration phase concluding visit.
    Phase II: at W3, W7 (only if consolidation cycle), W11, and only for patients authorized for the consolidation cycle at M6, M9, M12, M18 and M24 post the first NKR-2 administration.
    E.5.2Secondary end point(s)
    PHASE I
    A - NKR-2 cell kinetics and dynamics endpoints
    1) The evaluation of circulating NKR-2 in the peripheral blood and its kinetics post-injection.

    B - Safety endpoints
    2) The occurrence of AEs and SAEs and any toxicity linked to study participation until the end of the treatment follow-up (at M24).

    C - Clinical activity endpoints
    3) The overall survival (OS), relapse-free survival (RFS) and event-free survival (EFS) from study enrollment.
    4) The objective clinical response rate (ORR) and objective clinical benefit rate (OCBR) post the first NKR-2 administration.
    5) The duration of response for patients with objective clinical response
    6) The ORR and duration of second response among patients retreated with NKR-2.
    7) The cumulative incidence of relapse (CIR) and cumulative incidence of death (CID).
    8) The non-relapse mortality (NMR) rate.
    9) For AML patients: the incidence of CR, CRMRD-, CRi, MLFS, PR, or SD post NKR-2 administrations until the end of the treatment follow-up (at M24).
    10) For MDS patients: the incidence of CR, PR, marrow CR, cytogenic response, hematologic improvement or SD post NKR-2 administrations until the end of the treatment follow-up (at M24).

    Phase II:
    A - Safety endpoints
    1) The occurrence of DLTs during the administration phase,
    2) The occurrence of AEs and SAEs and any toxicity linked to study participation until the end of the treatment follow-up (at M24).
    B - Clinical activity endpoints
    3) The overall survival (OS), relapse-free survival (RFS) and event-free survival (EFS) from study enrollment.
    4) The objective clinical benefit rate (OCBR) post the first NKR-2 administration.
    5) The duration of response for patients with objective clinical response.
    6) The ORR and duration of second response among patients retreated with NKR-2.
    7) The cumulative incidence of relapse (CIR) and cumulative incidence of death (CID).
    8) The non-relapse mortality (NMR) rate.
    9) For AML patients: the incidence of CR, CRMRD-, CRi, MLFS, PR, or SD post NKR-2 administrations until the end of the treatment follow-up (at M24).
    10) For MDS patients: the incidence of CR, PR, marrow CR, cytogenic response, hematologic improvement or SD post NKR-2 administrations until the end of the treatment follow-up (at M24).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I:
    1) D1, D3, D8, D15, D22 – For all patients
    After D22 2 options are possible
    a.Patients in PD and/or not meeting all the criteria for consolidation cycle at Visit 8: D36, D78, M6, M9, M12, M18, M24
    b.Patients not in PD and meeting all the criteria for consolidation cycle at Visit 8: D36, D38, D43, D50, D57, D64, D78, M6, M9, M12, M18, M24
    2) Until M24
    3) N/A
    4)W3, W7 (only if consolidation cycle), W11, and only for patients authorized for the consolidation cycle at M6, M9, M12, M18 and M24 post the first NKR-2 administration
    5)N/A
    6) Idem 4)
    7) Idem 4)
    8)N/A
    9)Idem 4)
    10) Idem 4)


    Phase II:
    1) During the administration phase, up to administration phase concluding visit.
    From 2) to 10): idem Phase I
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II study to assess the safety and clinical efficacy
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study conclusion is the last treatment follow-up visit (visist 20 at M24) or death, whichever occurs first. Long-term safety follow-up conclusion is the last visit of the long-term safety follow-up at Y15 or death, whichever occurs first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years15
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 17
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients, including those withdrawn from study treatment (see Section 10.2.1), will be requested to attend follow-up visits for up to 15 years after 1st NKR-2 administration. Patients withdrawn from the study will not be contacted again. However, the patient will be still asked to attend a simplified follow-up procedure for 15 years after the enrollment.

    Long-term safety follow-up conclusion will take place at the last visit at Y15 (Visit 33) or death, whichever occurs first.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-01
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