Phase 3 Study of Tabelecleucel for EBV-Associated PTLD

This study is testing a treatment called tabelecleucel for people with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD). This condition can happen after a solid organ transplant (SOT) or a stem cell transplant (HCT). Participants in this study have already tried rituximab, or rituximab and chemotherapy, and these treatments didn't work. Tabelecleucel is a type of immunotherapy that uses special cells to fight the disease. The main goal is to see how many participants respond to tabelecleucel, and to understand its safety. You might be able to join if you've had a solid organ or stem cell transplant, have a confirmed diagnosis of EBV+ PTLD, and a suitable tabelecleucel product is available for you. The study is currently unclear on its recruitment status.

Study design
This is a Phase 3, open-label study, meaning both you and your doctors will know you are receiving tabelecleucel. It plans to enroll 115 participants.
What's involved
You would receive tabelecleucel intravenously (through a vein) on Days 1, 8, and 15 of each 5-week cycle. Treatment continues until the best response is achieved, side effects are too severe, other treatments are started, or tabelecleucel is no longer effective.
Compensation
Not stated in the trial record.
Follow-up
The main results will be measured up to 2 years after treatment to see how well tabelecleucel worked.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03394365

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

Recruiting
PHASE3All AgesInterventionalTreatment
Pierre Fabre Medicament
~115 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:tabelecleucel

At a glance

Recruiting sites
36 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 2 years
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
Solid Organ Transplant Complications
Lymphoproliferative Disorders
Allogeneic Hematopoietic Cell Transplant
Stem Cell Transplant Complications
71 sites across 42 states
California6
New York5
Illinois3
North Carolina3
Ohio3
Pennsylvania3
Texas3
Île-de-France Region3

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  • 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 PV2 years