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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT04554914

Run by

Pierre Fabre Medicament

People needed

190

Starts

2021-07-14

Expected to finish

2028-05-01

Last updated by the study team

2026-07-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of EBV+ disease.
• Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants from ≥ 1 year to < 16 years.
• Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.
• Cohort-specific Inclusion Criteria:
• For participants with CNS PTLD:
• R/R or newly diagnosed EBV+ CNS PTLD for whom the standard. first-line therapy is inappropriate, as determined by the investigator. The CNS PTLD is histologically confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with or without radiographically measurable intracranial disease with EBV detected in CSF.
• Participants with R/R disease must have had at least one prior line of systemic therapy and one of the following: radiographic disease progression per Lugano Classification during or after treatment or failure to achieve a CR or PR (defined by Lugano radiographic criteria) after standard first-line therapy.
• Participant may have systemic and CNS disease or CNS disease only.

You may not qualify if…

• Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.
• Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection.
• Suspected or confirmed Grade ≥ 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment.
• Need for vasopressor or ventilatory support at the time of enrollment.
• Prior therapy (in order of increasing washout period) prior to enrollment as follows:
• Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression.
• Within 8 weeks: prior tabelecleucel (> 8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab).
• Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
• Women who are breastfeeding or pregnant.
• Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment.
• Inability or unwillingness to comply with all study procedures.
• Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment).
• Any conditions that may put the study outcomes at undue risk (life expectancy < 60 days or any life-threatening illness, medical condition, or organ system dysfunction).

Where it is running

• University of California Los Angeles (UCLA) (Adults and Pediatrics) — Los Angeles, California, United States
• Children's Hospital of Orange County (Pediatrics [up to 25 years old]) — Orange, California, United States
• Lucile Packard Children's Hospital Stanford (Pediatrics only) — Palo Alto, California, United States
• University of California Davis Comprehensive Cancer Center (Adults and Pediatrics) — Sacramento, California, United States
• Sylvester Comprehensive Cancer Center/ University of Miami — Miami, Florida, United States
• Moffit Cancer Center (Adults only) — Tampa, Florida, United States
• Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old]) — Atlanta, Georgia, United States
• Emory University/Winship Cancer Institute (Adults [>= 16 years]) — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only) — Chicago, Illinois, United States
• University of Maryland Medical Center (Adults only) — Baltimore, Maryland, United States
• Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics) — Boston, Massachusetts, United States
• University of Michigan Rogel Cancer Center (Adults and Pediatrics) — Ann Arbor, Michigan, United States
• University of Minnesota (Adults only) — Minneapolis, Minnesota, United States
• Washington University in St. Louis (Adults only) — St Louis, Missouri, United States
• Columbia University Irving Medical Center (Adults only) — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics) — New York, New York, United States
• The Children's Hospital at Montefiore (Adults and Pediatrics) — The Bronx, New York, United States
• Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics) — Cleveland, Ohio, United States
• The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only) — Columbus, Ohio, United States
• Oregon Health and Science University (Adults and Pediatrics) — Portland, Oregon, United States
• Medical University of South Carolina (Adults and Pediatrics) — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center (Pediatrics only) — Dallas, Texas, United States
• MD Anderson (Adults and Pediatrics) — Houston, Texas, United States
• Uniklinikum Salzburg Landeskrankenhaus (Adults only) — Salzburg, State of Salzburg, Austria
• Medizinische Universität Wien (Adults only) — Vienna, State of Vienna, Austria

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.