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Donor immune cells take on Virus-Linked cancer after transplant

NCT ID NCT03394365

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 3 times

Summary

This phase 3 trial tests tabelecleucel, a cell therapy made from donor immune cells, in 115 organ or stem cell transplant patients who developed a rare cancer (EBV+ PTLD) after standard treatment failed. The goal is to see if it can shrink tumors and improve outcomes. Participants must have measurable disease and a suitable donor cell match.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tabelecleucel (a cell therapy using donor immune cells to fight the virus)
What this could lead to
If successful, this could offer a new treatment option for transplant patients with a rare, life-threatening complication when standard therapy fails.
What could go wrong
This is still an experimental therapy; it may not work for everyone, and there are risks like infusion reactions or graft-versus-host disease. The trial is relatively small (115 participants).

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 115 people

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

Started

Dec 2017

Expected to finish

Aug 2030

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: 1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT). 2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD. 3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor. 4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria. 5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD. 6. Males and females of any age. 7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants \< 16 years. 8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission. 9. Adequate organ function. 1. Absolute neutrophil count ≥ 1000/μL, (C-SOT) or ≥ 500/μL (C-HCT), with or without cytokine support. 2. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For C-HCT, platelet count \< 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the participant has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0). 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \< 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction. 10. Participant or participant's representative is willing and able to provide written informed consent. Exclusion Criteria: 1. Currently active Burkitt, T-cell, NK/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy. 2. Daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis. 3. Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete. 4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment. 5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment. 6. For C-HCT: active adenovirus viremia. 7. Need for vasopressor or ventilatory support. 8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment. 9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only). 10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception. 11. Inability to comply with study-related procedures. 12. Any medical condition or organ system dysfunction that in the investigator';s opinion, could compromise the participant's safety or ability to complete the study.

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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 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 Epstein-Barr virus+ associated post-transplant lymphoproliferative disease (EBV+ PTLD) Lymphoproliferative disorders Solid organ transplant complications Stem cell transplant complications

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Children's Hospital (Adults and Pediatrics)

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Arthur M Blank Hospital - Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)

    COMPLETED

    Torino, Torino, 10126, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)

    COMPLETED

    Milan, Milano, 20162, Italy

  • Baylor Scott and White Research Institute (Adults only)

    RECRUITING

    Dallas, Texas, 75246, United States

  • Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)

    COMPLETED

    Lille, Hauts-de-France, 59037, France

  • Centre Hospitalier Universitaire de Bordeaux (Adults only)

    COMPLETED

    Pessac, Aquitaine, 33600, France

  • Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)

    COMPLETED

    Liège, Brussels Capital, 4000, Belgium

  • Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)

    RECRUITING

    Los Angeles, California, 90027, United States

  • City of Hope (Adults and Pediatrics)

    COMPLETED

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation (Adults and Pediatrics)

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center (Adults and Pediatrics)

    COMPLETED

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute (Adults and Pediatrics)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fiona Stanley Hospital (Adults only)

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)

    COMPLETED

    Pavia, Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli (Adults only)

    COMPLETED

    Roma, Roma, 00168, Italy

  • Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)

    COMPLETED

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Duran i Reynals (Adults and Pediatrics)

    RECRUITING

    Badalona, BARCELONA, 8908, Spain

  • Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)

    RECRUITING

    Madrid, Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario La Fe (Adults and Pediatrics)

    RECRUITING

    Valencia, Valencia, 46009, Spain

  • Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital of the University of Pennsylvania (Adults only)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpital Necker-Enfants Malades (Pediatrics only)

    COMPLETED

    Paris, Île-de-France Region, 75015, France

  • Hôpital Saint Antoine (Adults only)

    COMPLETED

    Paris, Île-de-France Region, 75571, France

  • Hôpital Universitaire Pitié Salpêtrière (Adults only)

    COMPLETED

    Paris, Île-de-France Region, 75651, France

  • Imperial College Healthcare NHS Trust (Adults only)

    RECRUITING

    London, England, W12 0HS, United Kingdom

  • King's College Hospital NHS Foundation Trust (Adults only)

    COMPLETED

    London, England, SE5 9RS, United Kingdom

  • Loma Linda University Medical Center (Adults only)

    RECRUITING

    Loma Linda, California, 92354, United States

  • Loyola University Medical Center (Adults and Pediatrics)

    RECRUITING

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center (Pediatrics and Adult)

    RECRUITING

    Houston, Texas, 77030, United States

  • MedStar Georgetown University Hospital (Adults and Pediatrics)

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of South Carolina (Adults and Pediatrics)

    COMPLETED

    Charleston, South Carolina, 29425, United States

  • Medizinische Universitat Wien (Adults only)

    ACTIVE_NOT_RECRUITING

    Vienna, Austria, 1090, Austria

  • Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)

    COMPLETED

    New York, New York, 10065, United States

  • Montefiore Medical Center (Adults only)

    COMPLETED

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center (Pediatrics only)

    COMPLETED

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital (Pediatrics only)

    COMPLETED

    Columbus, Ohio, 43205, United States

  • Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ospedale Pediatrico Bambino Gesu (Pediatrics only)

    COMPLETED

    Roma, Roma, 165, Italy

  • Princess Margaret Cancer Centre (Adults only)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Royal Adelaide Hospital (Adults only)

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Saint Jude Children's Research Hospital (Pediatrics only)

    COMPLETED

    Memphis, Tennessee, 38105, United States

  • Sick Kids (Pediatrics only)

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • The Children's Hospital at Westmead (Pediatrics only)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Prince Charles Hospital (Adults only)

    COMPLETED

    Chermside, Queensland, 4032, Australia

  • The Royal Children's Hospital Melbourne (Pediatrics only)

    RECRUITING

    Melbourne, Victoria, 3052, Australia

  • UCLA Medical Center (Adults and Pediatrics)

    COMPLETED

    Los Angeles, California, 90095, United States

  • Universitair Ziekenhuis Leuven (Adults and Pediatrics)

    ACTIVE_NOT_RECRUITING

    Leuven, Flemish Brabant, 3000, Belgium

  • University Hospital Virgen del Rocio (Adults and Pediatrics)

    RECRUITING

    Seville, Spain, 41013, Spain

  • University Hospitals Birmingham NHS Foundation Trust (Adults only)

    RECRUITING

    Birmingham, England, B15 2GW, United Kingdom

  • University of California Davis Comprehensive Cancer Center (Adults only)

    COMPLETED

    Sacramento, California, 95817, United States

  • University of California San Diego Moores Cancer Center (Adults only)

    COMPLETED

    La Jolla, California, 92093, United States

  • University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)

    COMPLETED

    Chicago, Illinois, 60637, United States

  • University of Florida (Adults and Pediatrics)

    COMPLETED

    Gainesville, Florida, 32610, United States

  • University of Maryland School of Medicine (Adults only)

    COMPLETED

    Baltimore, Maryland, 21201, United States

  • University of Miami/Jackson Memorial Hospital (Adults only)

    RECRUITING

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)

    COMPLETED

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center (Adults only)

    COMPLETED

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)

    RECRUITING

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine (Adults only)

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine (Adults only)

    COMPLETED

    New York, New York, 10021, United States

  • Westmead Hospital (Adults only)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Winship Cancer Institute (Adults only)

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • Yale University (Adults and Pediatrics)

    COMPLETED

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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