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A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases

NCT04554914 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-04-27

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.

Conditions

  • Epstein-Barr Virus (EBV)-Associated Diseases
  • EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
  • EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)
  • EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
  • EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
  • Solid Organ Transplant Complications
  • Lymphoproliferative Disorders
  • Allogeneic Hematopoietic Cell Transplant
  • Stem Cell Transplant Complications
  • EBV+ Sarcomas
  • Leiomyosarcoma

Interventions

BIOLOGICAL

Tabelecleucel

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

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Glen Lew · Pierre Fabre Laboratories

  • Federica Cattaneo · Pierre Fabre Laboratories

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2027-06-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554914 on ClinicalTrials.gov