RecruitingPhase 2NCT04554914

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

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein Barr Virus Associated Diseases (EBVision)

Sponsor

Pierre Fabre Medicament

Enrollment

190 participants

Start Date

Jul 14, 2021

Study Type

INTERVENTIONAL

Conditions

Leiomyosarcoma Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications 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)EBV+ Sarcomas

Summary

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

Eligibility

Plain Language Summary

Simplified for easier understanding

This study evaluates tabelecleucel, a cell-based therapy that uses immune cells to fight cancers and other diseases caused by the Epstein-Barr virus (EBV) — the virus behind mononucleosis. It targets people whose EBV-related disease has returned or not responded to standard treatments. **You may be eligible if...** - You have been diagnosed with an EBV-positive disease (such as certain lymphomas or post-transplant lymphoproliferative disorder) - You are in reasonably good functional health - Your organs are functioning adequately - You have tried at least one prior treatment for relapsed or refractory disease **You may NOT be eligible if...** - You have certain active blood cancers such as Burkitt lymphoma, T-cell lymphoma, or Hodgkin lymphoma requiring systemic treatment - You have a serious uncontrolled infection - You have active hemophagocytic lymphohistiocytosis (an overactive immune response) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTabelecleucel

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

Locations(40)

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

Medizinische Universität Graz (Adults only)

Graz, Styria, Austria

Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)

Brussels, Brussles, Belgium

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)

Bruges, West-Vlaanderen, Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)

Roeselare, West-Vlaanderen, Belgium

Hôpital Saint-Eloi (Adults and Pediatrics)

Montpellier, Montpellier, France

Hôpital Necker-Enfants Malades (Adults and Pediatrics)

Paris, Paris, France

Hôpital Universitaire Pitié Salpêtrière (Adults only)

Paris, France

Azienda Ospedaliero-Universitaria Pisana (Adults only)

Pisa, Pisa, Italy

Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)

Roma, Roma, Italy

Ospedale Infantile Regina Margherita (Pediatrics only)

Torino, Torino, Italy

Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)

Barcelona, Barcelona, Spain

Hospital Universitario Ramón y Cajal (Adults only)

Madrid, Madrid, Spain

Hospital Universitario Virgen del Rocio (Adults and Pediatrics)

Seville, Sevilla, Spain

University Hospital Birmingham NHS Foundation Trust (Adults only)

Birmingham, England, United Kingdom

Great Ormond Street Hospital (Pediatrics only)

London, England, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04554914

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