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    Summary
    EudraCT Number:2016-000704-28
    Sponsor's Protocol Code Number:GCP#05.01.020
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-07-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000704-28
    A.3Full title of the trial
    A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter trial of transplantation of NiCord, stem cells from donated umbilical cord blood that were grown in a laboratory to expand their number versus unmanipulated umbilical cord blood for patients with cancers of the blood and lymph
    A.4.1Sponsor's protocol code numberGCP#05.01.020
    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 SponsorGamida Cell Ltd
    B.1.3.4CountryIsrael
    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 supportGamida Cell Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGamida Cell Ltd
    B.5.2Functional name of contact pointClinical trial department
    B.5.3 Address:
    B.5.3.1Street Address5, Nahum Hafzadi, Beit Ofer
    B.5.3.2Town/ cityJerusalem
    B.5.3.3Post code9548401
    B.5.3.4CountryIsrael
    B.5.4Telephone number97226595666
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1852
    D.3 Description of the IMP
    D.3.1Product nameNiCord (CF cultured fraction and NF non-cultured fraction)
    D.3.4Pharmaceutical form Dispersion 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 INNAllogeneic, ex vivo expanded, umbilical cord blood-derived, hematopoietic CD34+ progenitor cells
    D.3.9.3Other descriptive nameALLOGENEIC, EX VIVO EXPANDED, UMBILICAL CORD BLOOD-DERIVED, HEMATOPOIETIC CD34+ PROGENITOR CELLS
    D.3.9.4EV Substance CodeSUB181698
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number800000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllogeneic, non-expanded, umbilical cord blood-derived, hematopoietic mature myeloid and lymphoid cells
    D.3.9.3Other descriptive nameALLOGENEIC, NON-EXPANDED, UMBILICAL CORD BLOOD-DERIVED, HEMATOPOIETIC MATURE MYELOID AND LYMPHOID CELLS
    D.3.9.4EV Substance CodeSUB181699
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number400000000
    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 Yes
    D.3.11.3.2Gene therapy medical product No
    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 No
    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 No
    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
    High risk haematological malignancies
    E.1.1.1Medical condition in easily understood language
    cancer affecting blood, bone marrow, lymph nodes
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028534
    E.1.2Term Myelodysplastic syndrome NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006597
    E.1.2Term Burkitt's lymphoma NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076434
    E.1.2Term Hepatosplenic gamma-delta T-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025315
    E.1.2Term Lymphoma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036889
    E.1.2Term Prolymphocytic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073481
    E.1.2Term Enteropathy-associated T-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054481
    E.1.2Term Natural killer-cell leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054655
    E.1.2Term T-cell type acute leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10000836
    E.1.2Term Acute leukemia NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067837
    E.1.2Term Acute biphenotypic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054681
    E.1.2Term Undifferentiated type acute leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall study objective is to compare the safety and efficacy of NiCord single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy
    E.2.2Secondary objectives of the trial
    Not applicable - see primary and secondary endpoints sections
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.12-65 years of age
    2.Patients with one of the following HM: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), CMMoL or MDS/CMMoL overlap, Myelodysplastic Syndrome (MDS) and Lymphoma as defined in the protocol. Biphenotypic/undifferentiated/Prolymphocytic/Dendritic Cell Leukemias and Natural Killer Cell Malignancies in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR. Patients with CLL are not eligible regardless of disease status.
    3.CBU criteria as described in the protocol;
    4.Patients who will be starting conditioning prior to NiCord release for infusion (i.e., NiCord arrival on site in adequate condition) must have an additional partially HLA-matched CBU reserved as a BU to the NiCord arm in case of production failure. The BU CBU must be HLA-matched at 4-6/6 HLA class I(HLA-A&HLA-B, low resolution) and II (HLA-DRB1,high resolution) loci with the patient. A second BU CBU is recommended to be added in the below cases: If the BU CBU is HLA matched at 5-or 6/6, and contains a pre-cryopreserved total nucleated cell dose of<2.5x10^7 TNC/kg, OR a pre-cryopreserved CD34+ cell dose
    of<1.2 x10^5CD34+ cells/kg. If the BU CBU is HLA-matched at 4/6, and contains a pre-cryopreserved total nucleated cell dose of<3.5x10^7 TNC/kg, OR a pre cryopreserved CD34+ cell dose of
    <1.7x10^5CD34+cells/kg. In case of two BU CBUs, the second BU CBU must also be HLA-matched at 4-6/6 HLA class I(HLA-A&HLA-B, low resolution) and II (HLA-DRB1,high resolution) loci with the patient. The BU CBUs are recommended to have a combined pre-cryopreserved total
    nucleated cell dose of at least 3x10^7 TNC/kg.
    5.Patient's Performance score ≥70% by Karnofsky or Lansky
    6. Patient has sufficient physiologic reserves including: a.Cardiac: LVEF of ≥40% by echocardiogram, radionuclide scan or cardiac MRI, or Left ventricular shortening fraction ≥ 29%. b.PFT demonstrating FVC and FEV1 of >50% of predicted for age and cDLCO>50% of predicted for patients in whom pulmonary function testing can be performed c.Renal: Creatinine clearance test ≥60mL/min d.Hepatic: Serum Bilirubin<2.0 mg/dl; Hepatic transaminases<3xupper limit of normal range
    7.Females of childbearing potential, defined as any female who has experienced menarche and is not postmenopausal or permanently sterilized, agree to use an appropriate method of contraception from at least 7 days prior to conditioning regimen therapy until completion of FU procedures.
    8.Patient signs the written informed consent after being aware of the nature of the patient's disease and willingly consents to the treatment program after being informed of alternative treatments, potential risks, benefits, and discomforts
    E.4Principal exclusion criteria
    1.MDS or CML with "marked" or "3+" fibrosis
    2. CLL
    3.Fewer than 21 days have elapsed since initiation of the patient's last
    chemotherapy cycle and the initiation of the stem cell transplant
    preparative regimen (radiotherapy,intrathecal agents, hydroxyurea,
    tyrosine kinase inhibitors, hypomethylating agents, rituximab, blinatumomab and
    lenalidomide are not considered chemotherapy)
    4.Persistent clinically significant toxicities that, in the investigator's
    opinion, make the patient unsuitable for transplant
    5.Evidence of donor specific anti-HLA antibodies to the selected
    treatment CBU #1 (MFI>3000 to HLA A, B, C, or DRB1)
    6.Evidence of HIV infection or HIV positive serology
    7.Evidence of active Hepatitis B or Hepatitis C as determined by serology
    or PCR
    8.Pregnancy, as indicated by a positive serum or urine human chorionic
    gonadotrophin (HCG) test, or lactation
    9.Active malignancy other than that for which the UCB transplant is being performed within 12 months of enrollment. Fully resected
    cutaneous squamous cell or basal cell carcinoma or cervical carcinoma in
    situ within 12 months of enrollment will be permitted.
    10.Evidence of uncontrolled bacterial, fungal or viral infections or severe
    concomitant diseases, which in the judgment of the Principal
    investigator indicate that the patient could not tolerate transplantation
    11.Patients with presence of leukemic blasts in the central nervous
    system (CNS)
    12.Patients with an 8/8 allele level HLA-matched and readily available
    related or unrelated donor (whose stem cells can be collected in a timely
    manner without jeopardizing recipient outcome). Patients who have
    haploidentical related donors or syngeneic will not be excluded
    13.Prior allogeneic hematopoietic stem cell transplant
    14.Allergy to bovine products, gentamicin, or to any other product that
    may interfere with the treatment
    15.Psychologically incapable of undergoing bone marrow transplant
    (BMT) with associated strict isolation or documented history of medical
    non-compliance and/or psychiatric illness and/or social situations that
    would limit compliance with study requirements
    16.Enrolled in another interventional clinical trial or received an
    investigational treatment within 30 days prior to the approved date of
    randomization, unless documented approval obtained from Sponsor prior
    to the anticipated date of randomization, unless documented approval
    obtained from Sponsor prior to randomization
    E.5 End points
    E.5.1Primary end point(s)
    Assess the time to neutrophil engraftment following transplantation.
    Neutrophil engraftment is defined as achieving an absolute neutrophil
    count (ANC) ≥ 0.5 x 10^9/L on 3 consecutive measurements on
    different days with subsequent donor chimerism (≤10% host cells by
    peripheral blood chimerism or bone marrow chimerism if peripheral
    blood chimerism is not available). The day of neutrophil engraftment is
    designated as the first of the 3 consecutive measurements and must
    occur on or before 42 days post transplant (and also prior to infusion of
    any additional stem cell product).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not relevant
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    •Incidence of grade 2/3 bacterial or invasive fungal infections by 100
    days following transplantation
    •Days alive and out of hospital in the first 100 days following
    transplantation
    •Platelet engraftment by 42 days following transplantation
    Tertiary Endpoint:
    •Non-relapse mortality by 210 days following randomization
    Exploratory Endpoints:
    •Neutrophil engraftment by 16 days following transplantation
    •Time from transplantation to platelet engraftment
    •Duration of primary hospitalization
    •Non-relapse mortality by 130 days and 15 months following
    randomization
    •Overall survival at 210 days and 15 months following randomization
    •Disease-free survival at 15 months following randomization
    •Neutrophil engraftment by 42 days following transplantation
    •Acute GvHD grade II-IV and III-IV by 100 days following transplantation
    •Chronic GvHD (mild/moderate/severe) by 180 days and 1 year
    following transplantation
    •Secondary graft failure by 1 year following transplantation
    •Grade 3 viral infections by 180 days and 1 year following
    transplantation
    •Safety and tolerability of NiCord® transplantation
    •Relapse by 15 months following randomization
    •Relapse mortality by 15 months following randomization
    •Immune reconstitution at 28, 70, 100, 180, and 365 days following transplantation
    • Supplemental immune reconstitution assessments at a central laboratory (optional)
    •Health-related quality of life
    • Long-term clinical outcomes up to 5 years following transplantation (optional)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpt:
    d 100 following transplant
    d 100 following transplant
    d 42 following transplant
    Tertiary Endpt:
    day 210 following randomization
    Exploratory Endpoints:
    day 16 following transplant
    NR
    NR
    d 130 and 15 m following randomization
    d 210 & 15 m following randomization
    15 m following randomization
    d 42 following transplant
    d 100 following transplant
    d 180 & 1 yr following transplant
    1 yr following transplantation
    d 180 & 1 yr following transplant
    NR
    15 m following randomization
    15 m following randomization
    day 28, 70, 100, 180 and 365 following transplantation
    MultiPlex analyses (d 7, 14, 21, 28, 42, 56, 70, 100, 180, & day 365 visits) & T cell receptor analysis (at screening and on days 100, 180 and 365 visits)
    NR
    2 , 3, 4 & 5 yrs post transplantation
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    one or two Unmanipulated Umbilical Cord Blood Unit(s)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Israel
    Italy
    Netherlands
    Portugal
    Singapore
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    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 who enroll in the optional long-term follow up sub-study will be followed for up to 5 years post-transplantation.
    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 Decision2018-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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