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    Summary
    EudraCT Number:2017-002949-30
    Sponsor's Protocol Code Number:ATA129-EBV-302
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-01-10
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2017-002949-30
    A.3Full title of the trial
    Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for subjects after organ or cell transplantation after failure of prior treatment
    A.3.2Name or abbreviated title of the trial where available
    ALLELE study
    A.4.1Sponsor's protocol code numberATA129-EBV-302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/490/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAtara Biotherapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportAtara Biotherapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtara Biotherapeutics, Inc.
    B.5.2Functional name of contact pointAditi Mehta
    B.5.3 Address:
    B.5.3.1Street Address2380 Conejo Spectrum Street, Suite 200
    B.5.3.2Town/ cityThousands Oaks
    B.5.3.3Post code91320
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18057246932
    B.5.6E-mailamehta@atarabio.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1627
    D.3 Description of the IMP
    D.3.1Product nametabelecleucel
    D.3.2Product code ATA129
    D.3.4Pharmaceutical form Suspension for injection
    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 INNTABELECLEUCEL
    D.3.9.2Current sponsor codeATA129
    D.3.9.4EV Substance CodeSUB194902
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5×10E7 cells/ml
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic cell therapy medicinal product, 30 May 2016 Doc. Ref. EMA/CAT/327742/2016
    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 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Ebvallo
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Medicament
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/16/1627
    D.3 Description of the IMP
    D.3.1Product nametabelecleucel
    D.3.2Product code ATA129
    D.3.4Pharmaceutical form Suspension for injection
    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 INNTabelecleucel
    D.3.9.2Current sponsor codeATA129
    D.3.9.4EV Substance CodeSUB194902
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5×10E7 cells/ml
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic cell therapy medicinal product, 30 May 2016 Doc. Ref. EMA/CAT/327742/2016
    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 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
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease
    E.1.1.1Medical condition in easily understood language
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after failure of prior treatment
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10068349
    E.1.2Term Epstein-Barr virus associated lymphoproliferative disorder
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10075146
    E.1.2Term Post transplant Epstein-Barr virus associated lymphoproliferative disorder
    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
    -To determine the clinical benefit of tabelecleucel (ATA129; allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes [EBV-CTLs]) as measured by the objective response rate (ORR) in subjects with EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the following analysis cohorts (1) solid organ transplant (SOT) after failure of the following: a) rituximab (SOT-R), which includes subjects who did not receive chemotherapy and did not have a documented medical reason not to receive chemotherapy (SOT-Ro); or who were considered chemotherapy ineligible/inappropriate (SOT-R-Ci). b) rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab or (3) A combined population of SOT-R-Ci, SOT-R+C, and HCT who received commercial product or a product manufactured using a comparable process version (PV).
    E.2.2Secondary objectives of the trial
    - To evaluate duration of response (DOR) in the SOT and HCT cohorts separately
    - To evaluate ORR and DOR in the SOT and HCT cohorts combined
    -To evaluate ORR and DOR in subjects who received commercial product or a product manufactured using a comparable PV in the following: SOTR-Ci and SOT-R+C combined, and separately, HCT
    -To evaluate DOR in a combined population (SOT-R-Ci, SOT-R+C, and HCT) who received commercial product or a product manufactured using a comparable PV




    - To evaluate rates of complete response (CR) and partial response (PR)
    - To evaluate time to response and time to best response
    - To evaluate overall survival (OS)
    - To evaluate graft status (SOT subjects only)
    - To characterize the safety profile of tabelecleucel in this subject population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort);
    or prior allogeneic HCT (HCT cohort).
    2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD.
    3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.
    4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano
    Classification response criteria by positron emission tomography -diagnostic computed tomography, except when contraindicated or mandated by local practice, then magnetic resonance imaging may be used. For subjects with treated central nervous system (CNS) disease, head diagnostic computed tomography
    and/or brain/spinal magnetic resonance imaging as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
    5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy
    (SOT-R or HCT cohort) or rituximab plus any concurrent or sequentially administered
    chemotherapy regimen (SOT-R+C) for treatment of PTLD. Treatment failure is defined based on rituximab response as follows:
    a.Radiographic disease progression per Lugano Classification following a minimum cumulative dose
    of 1125 mg/m2 rituximab (typically, 3 weekly doses of 375 mg/m2), or
    b. Failure to achieve CR or PR, defined by Lugano radiographic criteria, after a minimum cumulative dose of 1500 mg/m2 rituximab (typically, 4 weekly doses of 375 mg/m2), or
    c. Relapse/progression of PTLD after a response to rituximab (SOT-R or HCT cohort) or
    rituximab plus chemotherapy (SOT-R+C), defined as radiographic and/or biopsy evidence of relapse/progression consistent with PTLD; if the underlying disease for which the subject underwent allogeneic HCT (HCT cohort) was lymphoma, biopsy confirmation of relapsed EBV+ PTLD is required.
    6. Males and females of any age.
    7. Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects < 16 years.
    8. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission.
    9. Adequate organ function:
    a. Absolute neutrophil count ≥ 1000/μL (SOT cohort) or ≥ 500/μL (HCT cohort), with or without
    cytokine support
    b. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For HCT cohort, platelet count < 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the subject has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute’s Common Terminology Criteria for Adverse Events, version 5.0)
    c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each < 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × the upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction (eg, elevated prothrombin time due to liver dysfunction, signs/symptoms of liver dysfunction such as asterixis, or similar).
    10. Subject or subject’s representative is willing and able to provide written informed consent.
    E.4Principal exclusion criteria
    1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T-cell lymphoma.
    2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or
    extracorporeal photopheresis.
    3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed
    chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.
    4. Suspected or confirmed grade ≥ 2 graft-versus-host disease per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.
    5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.
    6. For HCT cohort only: Active adenovirus viremia.
    7. Need for vasopressor or ventilatory support.
    8. Antithymocyte globulin or similar anti-T-cell antibody therapy ≤ 4 weeks prior to enrollment.
    9. Treatment with EBV-CTLs or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts); or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only).
    10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.
    11. Inability to comply with study-related procedures
    12. Any medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or ability to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    The ORR (CR or PR) obtained following administration of tabelecleucel with up to 2 different HLA restrictions in each of the following analysis cohorts:
    -SOT
    -HCT
    -A combined population (SOT-R-Ci, SOT-R+C, and HCT) following administration of commercial product or a product manufactured using a comparable PV
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    E.5.2Secondary end point(s)
    - DOR in the SOT and HCT cohorts separately.
    - ORR and DOR in SOT and HCT cohorts combined.
    - ORR and DOR in subjects who received commercial product or a product manufactured using a comparable PV in the following: SOT-R-Ci and SOT-R+C combined, and separately, HCT
    - DOR in a combined population (SOT-R-Ci, SOT-R+C, and HCT) who received commercial product or a product manufactured using a comparable PV
    - Rates of CR and PR
    - Time to response and time to best response
    - OS
    - Rates of allograft loss/rejection episodes (for SOT cohort only): loss is defined as allograft removal, resumption of renal replacement therapy (kidney), initiation of a ventricular assist device (heart), need for mechanical ventilation or extracorporeal membrane oxygenation (lung), re-transplant (any), or placement on a SOT list (any); rejection episodes will be defined according to appropriate criteria for the particular organ transplant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Australia
    Canada
    United Kingdom
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Spain
    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
    After treatment is completed or discontinued, subjects will be assessed for disease response every 3 months, up to 24 months from cycle 1 day 1, and every 6 months thereafter up to 5 years from cycle 1 day 1 for survival status.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 10
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 66
    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)
    none
    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 Decision2020-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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