A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (ALLELE)

May 20, 2026 updated by: Pierre Fabre Medicament

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

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT-R and SOT-R+C (Cohort [C]-SOT) or HCT after failure of rituximab (C-HCT).

SOT-R further included participants:

  1. who did not receive chemotherapy and did not have a documented medical reason not to receive chemotherapy (SOT-Ro) or
  2. who were considered chemotherapy ineligible/inappropriate (SOT-R-Ci)

Combined population (SOT-R-Ci, SOT-R+C, and HCT) and (SOT-R-Ci and SOT-R+C) who received commercial product, or a product manufactured using a comparable process version (PV) were also used for analysis of outcomes.

Enrollment will be preceded by confirmation of availability of partially human leukocyte antigen (HLA) matched and restricted tabelecleucel for the participant.

Study procedures and product administration will be the same for each cohort. Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, participants will receive intravenous tabelecleucel at a dose of 2 × 10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. Treatment will continue until maximal response, unacceptable toxicity, initiation of non protocol therapy, or failure of tabelecleucel with up to 2 different HLA restrictions (C-SOT) or up to 4 different HLA restrictions (C-HCT). The study includes a total of 5 years of follow-up for disease and survival status for participants enrolled before or after 09 October 2023 to reach the initial sample size of 33 participants in both cohorts. For all other participants enrolled after 09 October 2023 and after the initial sample of 33 participants in both cohorts has been reached in both cohorts, the follow-up will be every 3 months, up to 12 months, as assessed on anniversary of Cycle 1 Day 1. For responders, the follow-up will be 12 months from the date of initial response.

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead (Pediatrics only)
        • Contact:
          • Caroline Bateman, MD
          • Phone Number: 2 9845 2185
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital (Adults only)
        • Contact:
          • Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA
          • Phone Number: 2 9845 6352
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Completed
        • The Prince Charles Hospital (Adults only)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital (Adults only)
        • Contact:
          • Devendra Hiwase, MD
          • Phone Number: 870740000
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Recruiting
        • The Royal Children's Hospital Melbourne (Pediatrics only)
        • Contact:
          • Theresa Cole, BM, MRCPCH, FRACP
          • Phone Number: 0393455522
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital (Adults only)
        • Contact:
          • Duncan Purtill, MD, MBBS, FRACP, FRCPA
          • Phone Number: (8) 6152 3788
  • Austria
    • Austria
      • Vienna, Austria, Austria, 1090
        • Active, not recruiting
        • Medizinische Universitat Wien (Adults only)
  • Belgium
    • Brussels Capital
      • Liège, Brussels Capital, Belgium, 4000
        • Completed
        • Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Active, not recruiting
        • Universitair Ziekenhuis Leuven (Adults and Pediatrics)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital (Adults and Pediatrics)
        • Contact:
          • Victor Lewis, MD
          • Phone Number: (403) 955-7203
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Sick Kids (Pediatrics only)
        • Contact:
          • Joerg Krueger, MD
          • Phone Number: (416) 813-7654
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre (Adults only)
        • Contact:
          • Igor Novitzky Basso, MD
          • Phone Number: (416) 315-1147
  • France
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Completed
        • Centre Hospitalier Universitaire de Bordeaux (Adults only)
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Completed
        • Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Completed
        • Hôpital Necker-Enfants Malades (Pediatrics only)
      • Paris, Île-de-France Region, France, 75571
        • Completed
        • Hôpital Saint Antoine (Adults only)
      • Paris, Île-de-France Region, France, 75651
        • Completed
        • Hôpital Universitaire Pitié Salpêtrière (Adults only)
  • Italy
    • Milano
      • Milan, Milano, Italy, 20162
        • Completed
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Completed
        • Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)
    • Roma
      • Roma, Roma, Italy, 00168
        • Completed
        • Fondazione Policlinico Universitario Agostino Gemelli (Adults only)
      • Roma, Roma, Italy, 165
        • Completed
        • Ospedale Pediatrico Bambino Gesu (Pediatrics only)
    • Torino
      • Torino, Torino, Italy, 10126
        • Completed
        • Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)
  • Spain
    • BARCELONA
      • Badalona, BARCELONA, Spain, 8908
        • Recruiting
        • Hospital Duran i Reynals (Adults and Pediatrics)
        • Contact:
          • Eva González-Barca, MD
          • Phone Number: 932274778
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)
        • Contact:
          • Pere Barba, MD
          • Phone Number: 4897 93 274 6100
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)
        • Contact:
          • Lucrecia Yanez, MD
          • Phone Number: 942202573
    • Madrid
      • Madrid, Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)
        • Contact:
          • Rebeca Bailen, MD
          • Phone Number: 91 426 98 26
    • Spain
      • Seville, Spain, Spain, 41013
        • Recruiting
        • University Hospital Virgen del Rocio (Adults and Pediatrics)
        • Contact:
          • Jose Perez-Simon, MD
          • Phone Number: 955 013260
    • Valencia
      • Valencia, Valencia, Spain, 46009
        • Recruiting
        • Hospital Universitario La Fe (Adults and Pediatrics)
        • Contact:
          • Juan Montoro, MD
          • Phone Number: 961 245 876
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust (Adults only)
        • Contact:
          • Sridhar Chaganti, MD
          • Phone Number: 1214242000
      • London, England, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust (Adults only)
        • Contact:
          • Eduardo Olavarria, MD
          • Phone Number: 208 383 2134
      • London, England, United Kingdom, SE5 9RS
        • Completed
        • King's College Hospital NHS Foundation Trust (Adults only)
  • United States
    • California
      • Duarte, California, United States, 91010
        • Completed
        • City of Hope (Adults and Pediatrics)
      • La Jolla, California, United States, 92093
        • Completed
        • University of California San Diego Moores Cancer Center (Adults only)
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center (Adults only)
        • Contact:
          • Aditya Sharma, MD
          • Phone Number: 1 (909) 558-4910
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
        • Contact:
          • Amber Medina
          • Phone Number: 323-361-5654
        • Contact:
          • Neena Kapoor, MD
          • Phone Number: 323-361-2434
      • Los Angeles, California, United States, 90095
        • Completed
        • UCLA Medical Center (Adults and Pediatrics)
      • Sacramento, California, United States, 95817
        • Completed
        • University of California Davis Comprehensive Cancer Center (Adults only)
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Completed
        • Yale University (Adults and Pediatrics)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital (Adults and Pediatrics)
        • Contact:
          • Udeme Ekong, MD
          • Phone Number: 202-444-3514
    • Florida
      • Gainesville, Florida, United States, 32610
        • Completed
        • University of Florida (Adults and Pediatrics)
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami/Jackson Memorial Hospital (Adults only)
        • Contact:
          • Amer Beitinjaneh, MD, MPH, MSc
          • Phone Number: 1 (305) 243-9848
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Winship Cancer Institute (Adults only)
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Arthur M. Blank Hospital (Pediatrics)
        • Contact:
          • Suhag Parikh, MD
          • Phone Number: 1 (404) 727-8930
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
        • Contact:
          • Sonali Chaudhury, MD
          • Phone Number: 312-227-4090
      • Chicago, Illinois, United States, 60637
        • Completed
        • University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center (Adults and Pediatrics)
        • Contact:
          • Patrick Hagen, MD
          • Phone Number: 1 (708) 327-2241
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland School of Medicine (Adults only)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
        • Contact:
          • Sarah Nikiforow, MD
          • Phone Number: 617-632-6640
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine (Adults only)
        • Contact:
          • Armin Ghobadi, MD
          • Phone Number: (314) 747-8439
    • New York
      • New York, New York, United States, 10021
        • Completed
        • Weill Cornell Medicine (Adults only)
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Medical Center (Adults and Pediatrics)
      • New York, New York, United States, 10065
        • Completed
        • Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
      • The Bronx, New York, United States, 10467
        • Completed
        • Montefiore Medical Center (Adults only)
      • The Bronx, New York, United States, 10467
        • Completed
        • Montefiore Medical Center (Pediatrics only)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Completed
        • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
        • Contact:
          • Michael Kent, MD
          • Phone Number: 704-381-9900
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute (Adults and Pediatrics)
        • Contact:
          • Matthew McKinney, MD
          • Phone Number: 1 (919) 684-8111
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation (Adults and Pediatrics)
        • Contact:
          • Rabi Hanna, MD
          • Phone Number: 1 (216) 444-0663
      • Columbus, Ohio, United States, 43205
        • Completed
        • Nationwide Children's Hospital (Pediatrics only)
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)
        • Contact:
          • Robert Baiocchi, MD, PhD
          • Phone Number: (614) 293-3196
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
        • Contact:
          • Andy Chen, MD
          • Phone Number: 1 (503) 494-5058
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania (Adults only)
        • Contact:
          • Sunita Nasta, MD
          • Phone Number: 215-662-6933
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)
        • Contact:
          • Caitlin Elgarten, MD
          • Phone Number: 1 267-425-7964
      • Pittsburgh, Pennsylvania, United States, 15232
        • Completed
        • University of Pittsburgh Medical Center (Adults only)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Completed
        • Medical University of South Carolina (Adults and Pediatrics)
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Completed
        • Saint Jude Children's Research Hospital (Pediatrics only)
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
        • Contact:
          • Bhagirathbhai Dholaria, MD
          • Phone Number: 1 (615) 875-3112
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott and White Research Institute (Adults only)
        • Contact:
          • Luis Pineiro, MD
          • Phone Number: 214-370-1000
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
        • Contact:
          • Tamra Slone, MD
          • Phone Number: 1 (214) 648-3150
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center (Pediatrics and Adult)
        • Contact:
          • Priti Tewari, MD
          • Phone Number: 1 713-632-5087
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Completed
        • Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).
  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 (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI 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 (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.
  6. Males and females of any age.
  7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants < 16 years.
  8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission.

  9. Adequate organ function.

    1. Absolute neutrophil count ≥ 1000/μL, (C-SOT) or ≥ 500/μL (C-HCT), with or without cytokine support.
    2. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For C-HCT, platelet count < 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the participant 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 [CTCAE], version 5.0).
    3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each < 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × 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.
  10. Participant or participant's representative is willing and able to provide written informed consent.

Exclusion Criteria:

  1. Currently active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.
  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 participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.
  4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) 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 C-HCT: 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 Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT 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 participant's safety or ability to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort SOT-R (C-SOT-R)
Participants with EBV+ PTLD following SOT that has failed rituximab will receive IV tabelecleucel.
Biological: tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Names:
  • tab-cel®
  • ATA129
  • EBV-CTL
  • Ebvallo®
Experimental: Cohort SOT-R+C (C-SOT-R+C)
Participants with EBV+ PTLD following SOT that has failed both rituximab and chemotherapy will receive IV tabelecleucel.
Biological: tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Names:
  • tab-cel®
  • ATA129
  • EBV-CTL
  • Ebvallo®
Experimental: Cohort HCT (C-HCT)
Participants with EBV+ PTLD following HCT that has failed rituximab containing regimen will receive IV tabelecleucel.
Biological: tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Other Names:
  • tab-cel®
  • ATA129
  • EBV-CTL
  • Ebvallo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 2 years
2 years
Time to Response
Time Frame: 2 years
2 years
ORR and DOR in Participants who Received Commercial Product or a Product Manufactured Using a Comparable PV in the Analysis Cohorts C-SOT-R-Ci and C-SOT-R+C Separately and Combined, and in the Analysis Cohort C-HCT
Time Frame: 2 years
2 years
Rates of Complete Response (CR) and Partial Response (PR)
Time Frame: 2 years
2 years
Time to Best Response
Time Frame: 2 years
2 years
Rates of Allograft Loss or Rejection Episodes (Analysis Cohort C-SOT)
Time Frame: 2 years
2 years
Duration of Response (DOR) in the Analysis Cohorts C-SOT and C-HCT Separately
Time Frame: 2 years
2 years
ORR in the Analysis Cohorts C-SOT and C-HCT Combined
Time Frame: 2 years
2 years
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Study Director: Glen Lew, Pierre Fabre Laboratories
  • Study Director: Federica Cattaneo, Pierre Fabre Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2017

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATA129-EBV-302/F60085DL302
  • 2024-516622-57-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoproliferative Disorders

Clinical Trials on tabelecleucel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe