ATA129 for Solid Organ Transplant Subjects With EBV-PTLD After Failure of Rituximab or Rituximab and Chemotherapy

Description

This is a multicenter, open-label, single-arm phase 3 trial to assess the efficacy and safety of ATA129 for the treatment of Epstein Barr Virus-associated post-transplant lymphoproliferative disease (EBV-PTLD) in the setting of solid organ transplant (SOT) after failure of rituximab or rituximab plus chemotherapy.

Study Start Date

December, 29 2017

Estimated Completion Date

November 2020

Interventions

  • Biological: ATA129

Study ID

Atara Biotherapeutics -- ATA129-EBV-302

Status

Recruiting

Trial ID

NCT03394365

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

66

Sponsor

Atara Biotherapeutics

Inclusion Criteria

    1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these 2. A diagnosis of locally-assessed, biopsy-proven EBV-PTLD with a pathology sample available for central review 3. Availability of appropriate HLA partially-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). For subjects with treated central nervous system (CNS) disease, a head CT and/or brain/spinal magnetic resonance imaging (MRI) as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria. 5. Treatment failure of rituximab monotherapy (Cohort A) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (Cohort B) for treatment of PTLD 6. Males and females of any age 7. Eastern Cooperative Oncology Group (ECOG) performance status ? 3 for subjects aged > 16 years Lansky score ? 20 for subjects from birth to 16 years 8. Adequate organ function 1. Absolute neutrophil count ? 1000/?L, with or without cytokine support 2. Platelet count ? 50,000/?L, with or without transfusion or cytokine support 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin < 3×ULN however, ALT, AST, and TBILI each ? 5×ULN is acceptable if the elevation is considered due to PTLD involvement of the liver. 4. Creatinine < 3×ULN 9. 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. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving treatment at enrollment 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 agent (eg ipilimumab, pembrolizumab, nivolumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1 5. Need for vasopressor or ventilatory support 6. Antithymocyte globulin or similar anti-T cell antibody therapy ? 4 weeks prior to Cycle 1 Day 1 7. Previous treatment with EBV-targeted cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of Cycle 1 Day 1 8. Pregnancy 9. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception 10. 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
Columbia University Medical Center - New York, New York 44.8 miles Ran Reshef MD 212-342-0530 rr3036@cumc.columbia.edu
Leonard M Miller School of Medicine Miami Transplant Institute - Miami, Florida 1,141.0 miles Amer Beitinjaneh MD MPH MSc 305-243-6626 abeitinjaneh@miami.edu

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