This is a multicenter, open label, single-arm, phase 3 trial to assess the efficacy and safety of ATA129 for the treatment of EBV-associated post-transplant lymphoproliferative disease (PTLD) in the setting of allogeneic hematopoietic cell transplant (alloHCT) after failure of rituximab.



Eligible Ages
All ages
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. Prior allogeneic hematopoietic cell transplant
  2. A diagnosis of locally-assessed, biopsy-proven EBV-PTLD with a pathology sample available for central review
  3. Availability of appropriate partially HLA-matched and restricted ATA129 cell product
  4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease (using Lugano Classification response criteria) by positron emission tomography (PET)/computed tomography (CT). Baseline scans must be of acceptable quality to the central radiology laboratory prior to Cycle 1 Day 1.
  5. Failure of rituximab for first-line treatment of PTLD
  6. Males and females of any age
  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 for patients aged > 16 years; Lansky score ≥ 20 for subjects from birth to 16 years
  8. Underlying primary disease, for which the subject underwent transplant, is in morphologic remission
  9. Adequate organ function
  10. Absolute neutrophil count ≥ 500/µL, with or without cytokine support
  11. Platelet count ≥ 50,000/µL, with or without transfusion support; 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 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 4.03)
  12. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) < 3 x the upper limit of normal (ULN); however, ALT, AST, and TBILI each ≤ 5 x ULN is acceptable if the elevation is considered by the investigator to be due to PTLD involvement of the liver
  13. Creatinine < 3 x ULN
  14. Subject or subject's representative is willing and able to provide written informed consent

Exclusion Criteria

  1. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
  2. History of central nervous system (CNS) PTLD
  3. Grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment
  4. Ongoing or recent use of a checkpoint inhibitor (eg, nivolumab, pembrolizumab, ipilimumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1
  5. Active adenovirus viremia
  6. Need for vasopressor or ventilatory support
  7. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to Cycle 1 Day 1
  8. Treatment with EBV-targeted cytotoxic T lymphocytes, chimeric antigen receptor (CAR)-T cells directed against B cells, or unselected donor lymphocyte infusion (DLI) within 8 weeks of Cycle 1 Day 1
  9. Pregnancy
  10. 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 procedures

Study Design

Phase 3
Study Type
Intervention Model
Single Group Assignment
Primary Purpose
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
ATA129 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA129 at a dose of 2 x 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 multiple ATA129 cell products.
  • Biological: ATA129
    ATA129 is an allogeneic cellular immunotherapy for the treatment of EBV-associated malignancies and diseases.
    Other names:
    • tabelecleucel
    • tab cel™
    • EBV-CTLs

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
David Loeb, MD, PhD

More Details

Atara Biotherapeutics

Study Contact

Atara Biotherapeutics
(805) 603-4856

Detailed Description

This is a multicenter, open label, single-arm, phase 3 trial to assess the efficacy and safety of ATA129 for the treatment of EBV-PTLD in the setting of alloHCT after failure of rituximab.

ATA129 will be selected for the subject from the bank of available ATA129 cell products based on matching ≥ 2 HLA alleles, at least one of which is a restricting HLA allele, shared between the ATA129 donor and the subject's EBV-PTLD. Sites will provide high resolution subject and subject's graft donor HLA typing results and other information as required by the protocol.

ATA129 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA129 at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.