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Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab

Trial Status: Complete

This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Inclusion Criteria

  • Prior allogeneic hematopoietic cell transplant
  • A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD with a pathology sample available for central review
  • Availability of appropriate partially HLA-matched and restricted tabelecleucel cell product
  • Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score >= 3) systemic disease (using Lugano Classification response criteria) by positron emission tomography (PET)-diagnostic computed tomography (CT). Baseline scans must be of acceptable quality to the central radiology laboratory prior to Cycle 1 Day 1.
  • Failure of rituximab for first-line treatment of PTLD. Note: Subjects with CD20 negative disease are eligible to enroll without prior anti-CD20 therapy after failure of first-line treatment (reduction of immunosuppression is not considered first-line therapy) and discussion with the sponsor's medical monitor.
  • Males and females of any age
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 3 for subjects aged > 16 years; Lansky score >= 20 for subjects from birth to 16 years
  • Underlying primary disease, for which the subject underwent transplant, is in morphologic remission
  • Adequate organ function
  • Absolute neutrophil count >= 500/µL, with or without cytokine support
  • 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 5.0)
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each < 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
  • Creatinine < 3 x ULN
  • Subject or subject's representative is willing and able to provide written informed consent

Exclusion Criteria

  • Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, methotrexate, or extracorporeal photopheresis
  • History of central nervous system (CNS) PTLD
  • Grade >= 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment
  • 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
  • Active adenovirus viremia
  • Need for vasopressor or ventilatory support
  • Antithymocyte globulin or similar anti-T cell antibody therapy <= 4 weeks prior to Cycle 1 Day 1
  • Treatment with Epstein-Barr virus 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
  • Pregnancy
  • Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
  • Inability to comply with study-related procedures

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Kim Kelly
Phone: 310-206-8309
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
Children's Hospital Colorado
Status: COMPLETED

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: COMPLETED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Sunita Philip
Phone: 410-328-8199

Massachusetts

Boston
Boston Children's Hospital
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ADMINISTRATIVELY_COMPLETE

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: COMPLETED
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: COMPLETED

This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and

safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of allogeneic HCT after

failure of rituximab.

Tabelecleucel will be selected for the subject from the bank of available tabelecleucel cell

products based on matching >= 2 human leukocyte antigen (HLA) alleles, at least one of which

is a restricting HLA allele, shared between the tabelecleucel 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.

Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle,

subjects will receive intravenous (IV) tabelecleucel at a dose of 2×10^6 cells/kg on Days 1,

8, and 15, followed by observation through Day 35.

NOTE, 29 April 2020: Study sites/locations with status "completed" may be screening EBV+ PTLD

HCT subjects in clinical study ATA129-EBV-302 (NCT03394365).

NOTE, 16 February 2021: all study sites have closed and all data has been transferred to the

clinical study database for monitoring under ATA129-EBV-302 (NCT03394365).

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Atara Biotherapeutics

  • Primary ID ATA129-EBV-301
  • Secondary IDs NCI-2018-00293
  • Clinicaltrials.gov ID NCT03392142