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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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)

A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases (NCT04554914) is a Phase 2 interventional studying Epstein-Barr Virus (EBV)-Associated Diseases and EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), sponsored by Pierre Fabre Medicament. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Epstein-Barr Virus (EBV)-Associated Diseases and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 190 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Epstein-Barr Virus (EBV)-Associated Diseases subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator. Cohort-specific Who May Qualify: - 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 diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: - 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 weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

BIOLOGICAL

Tabelecleucel

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04554914), the sponsor (Pierre Fabre Medicament), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04554914 clinical trial studying?

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04554914?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04554914?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04554914. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04554914. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.