CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 115 target
Drug / intervention
tabelecleucelbiological
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Prior solid organ transplant (kidney, liver, heart, lung, pancreas, small bowel, or combinations) or prior allogeneic HCT
  • ✓Biopsy-proven EBV+ PTLD diagnosis
  • ✓Appropriate partially HLA-matched and restricted tabelecleucel confirmed by sponsor
  • ✓Measurable FDG-avid (Deauville ≥3) systemic disease on PET-CT or MRI per Lugano Classification
Key exclusion· 12
  • ✕Currently active Burkitt, T-cell, NK/T-cell lymphoma, Hodgkin, plasmablastic, transformed lymphoma, hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
  • ✕Daily steroids >0.5 mg/kg prednisone or equivalent, ongoing methotrexate, or extracorporeal photopheresis
  • ✕Untreated or actively treated CNS PTLD (excluded; previously treated CNS PTLD allowed if therapy complete)
  • ✕Grade ≥2 graft-versus-host disease at enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03394365
NCT03394365Phase 3RecruitingOn Track
Long Recruiting
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Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

Pierre Fabre Medicament·interventional·Posted Jan 9, 2018·Updated May 22, 2026

In Brief

A Phase 3 clinical trial evaluating tabelecleucel for Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) and 4 related conditions. Currently recruiting, targeting 115 participants across 71 sites in 9 countries.

Detailed Summary

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant, Stem Cell Transplant Complications
CountriesAustralia, Austria, Belgium, Canada, France, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
2018201920202021202220232024202520262027202820292030
First PostedJan 9, 2018
Enrollment StartDec 29, 2017
Primary CompletionMay 31, 2030
Study CompletionAug 1, 2030
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 8.5 years agoPrimary completion in 3.9 years

Interventions

tabelecleucelbiological

Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.