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New cell therapy targets Epstein-Barr virus in immune-compromised patients

NCT ID NCT04554914

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests an experimental cell therapy called tabelecleucel in 190 people with diseases caused by the Epstein-Barr virus (EBV), including certain lymphomas and post-transplant complications. The treatment uses specially prepared immune cells to fight the virus. The main goal is to see if tumors shrink or disappear, while also monitoring safety and survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

disease related to hematopoietic stem cell transplant disease related to solid organ transplantation Epstein-Barr virus infection Epstein-Barr virus-associated lymphoproliferative disorder Epstein-Barr virus-related tumor immunodeficiency-associated lymphoproliferative disease inborn error of immunity leiomyosarcoma lymphoproliferative syndrome post-transplant lymphoproliferative disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allogeneic hematopoietic cell transplant EBV+ lymphoproliferative disease with acquired (non-congenital) immunodeficiency (EBV+ aid LPD) EBV+ lymphoproliferative disease with primary immunodeficiency (EBV+ pid LPD) EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) EBV+ posttransplant lymphoproliferative disease in central nervous system (EBV+ CNS PTLD) EBV+ sarcomas Epstein-Barr virus (EBV)-associated diseases Leiomyosarcoma Lymphoproliferative disorders Solid organ transplant complications Stem cell transplant complications

Contacts and locations

Locations

  • Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)

    Roeselare, West-Vlaanderen, 8800, Belgium

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

    Bruges, West-Vlaanderen, 8000, Belgium

  • Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)

    Chicago, Illinois, 60611, United States

  • Azienda Ospedaliero-Universitaria Pisana (Adults only)

    Pisa, Pisa, 56126, Italy

  • Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])

    Atlanta, Georgia, 30322, United States

  • Children's Hospital of Orange County (Pediatrics [up to 25 years old])

    Orange, California, 92868, United States

  • Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center (Adults only)

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)

    Boston, Massachusetts, 02215, United States

  • Emory University/Winship Cancer Institute (Adults [>= 16 years])

    Atlanta, Georgia, 30322, United States

  • Great Ormond Street Hospital (Pediatrics only)

    London, England, WC1N 3JH, United Kingdom

  • Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal (Adults only)

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio (Adults and Pediatrics)

    Seville, Sevilla, 41013, Spain

  • Hôpital Necker-Enfants Malades (Adults and Pediatrics)

    Paris, Paris, 75015, France

  • Hôpital Saint-Eloi (Adults and Pediatrics)

    Montpellier, Montpellier, 34295, France

  • Hôpital Universitaire Pitié Salpêtrière (Adults only)

    Paris, 75013, France

  • Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)

    Brussels, Brussles, 1020, Belgium

  • Lucile Packard Children's Hospital Stanford (Pediatrics only)

    Palo Alto, California, 94304, United States

  • MD Anderson (Adults and Pediatrics)

    Houston, Texas, 77030, United States

  • Medical University of South Carolina (Adults and Pediatrics)

    Charleston, South Carolina, 29425, United States

  • Medizinische Universität Graz (Adults only)

    Graz, Styria, 8036, Austria

  • Medizinische Universität Wien (Adults only)

    Vienna, State of Vienna, 1090, Austria

  • Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)

    New York, New York, 10065, United States

  • Moffit Cancer Center (Adults only)

    Tampa, Florida, 33612, United States

  • Oregon Health and Science University (Adults and Pediatrics)

    Portland, Oregon, 97239, United States

  • Ospedale Infantile Regina Margherita (Pediatrics only)

    Torino, Torino, 10126, Italy

  • Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)

    Roma, Roma, 00165, Italy

  • Sylvester Comprehensive Cancer Center/ University of Miami

    Miami, Florida, 33136, United States

  • The Children's Hospital at Montefiore (Adults and Pediatrics)

    The Bronx, New York, 10467, United States

  • The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)

    Columbus, Ohio, 43210, United States

  • Uniklinikum Salzburg Landeskrankenhaus (Adults only)

    Salzburg, State of Salzburg, 5020, Austria

  • University Hospital Birmingham NHS Foundation Trust (Adults only)

    Birmingham, England, B15 2TH, United Kingdom

  • University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)

    Sacramento, California, 95817, United States

  • University of California Los Angeles (UCLA) (Adults and Pediatrics)

    Los Angeles, California, 90095, United States

  • University of Maryland Medical Center (Adults only)

    Baltimore, Maryland, 21201, United States

  • University of Michigan Rogel Cancer Center (Adults and Pediatrics)

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota (Adults only)

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern Medical Center (Pediatrics only)

    Dallas, Texas, 75390, United States

  • Washington University in St. Louis (Adults only)

    St Louis, Missouri, 63108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.