ATA129 for Allogeneic Hematopoietic Cell Transplant Subjects With EBV-PTLD After Failure of Rituximab

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-associated post-transplant lymphoproliferative disease (PTLD) in the setting of allogeneic hematopoietic cell transplant (alloHCT) after failure of rituximab.

Study Start Date

December, 29 2017

Estimated Completion Date

November 2020

Interventions

  • Biological: ATA129

Study ID

Atara Biotherapeutics -- ATA129-EBV-301

Status

Recruiting

Trial ID

NCT03392142

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

33

Sponsor

Atara Biotherapeutics

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 1. Absolute neutrophil count ? 500/µL, with or without cytokine support 2. 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) 3. 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 4. Creatinine < 3 x ULN 10. 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

Gender

All

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles Lisa Gennarini MD 718-920-2460 lfigueir@montefiore.org
St Jude Childrens Research Hospital - Memphis, Tennessee 1,003.6 miles Ashok Srinivasan MD 901-595-4720 ashok.srinivasan@stjude.org
University of Miami Leonard M Miller School of Medicine Miami Transplant Institute - Miami, Florida 1,141.0 miles Amer Beitinjaneh MD 305-243-6626 abeitinjaneh@miami.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.