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Study of Tabelecleucel for Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Transplant Treatment Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD). This disease can occur in patients who have undergone organ or cell transplants and is associated with the Epstein-Barr virus. The study is investigating a treatment called tabelecleucel, also known by its code name ATA129. Tabelecleucel is a type of cell therapy that uses specially prepared cells to target and fight the virus-related disease.

The purpose of the study is to determine the clinical benefit of tabelecleucel in patients with EBV+ PTLD who have not responded to previous treatments, such as rituximab or rituximab combined with chemotherapy. Participants in the study will receive tabelecleucel through an injection into their veins. The study will monitor how well the treatment works and how the disease responds over time.

Participants will be observed throughout the study to assess the effects of the treatment. The study aims to provide valuable information on the effectiveness of tabelecleucel for patients with EBV+ PTLD, offering insights into potential new treatment options for those who have not had success with existing therapies. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on previous organ or cell transplantation and a diagnosis of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD).

    The availability of a suitable partially matched tabelecleucel is verified.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of tabelecleucel, a dispersion for injection, given intravenously.

    The dosage ranges from 2.8 × 10^7 to 7.3 × 10^7 cells/mL.

  3. Step 3

    Treatment administration

    Tabelecleucel is administered intravenously. The frequency and duration of administration are determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and assessment

    Regular monitoring is conducted to assess the response to treatment using imaging techniques such as positron emission tomography (PET) or magnetic resonance imaging (MRI) as appropriate.

    The objective response rate (ORR) is evaluated to determine the clinical benefit of the treatment.

  5. Step 5

    Completion of treatment

    The study aims to measure the duration of response (DOR) and overall survival (OS) among participants.

    The study is estimated to conclude by June 15, 2027.

Who can join the trial?

12 criteria

  • The patient must have had a prior solid organ transplant (like kidney, liver, heart, lung, pancreas, or small bowel) or a prior allogeneic hematopoietic cell transplant (a type of bone marrow transplant).
  • The patient or their representative must be willing and able to sign a written consent form to participate in the study.
  • The patient must have a confirmed diagnosis of a specific disease called **EBV+ PTLD**, which is related to the Epstein-Barr virus.
  • The study sponsor must confirm that the patient has access to a suitable treatment called **tabelecleucel**, which is partially matched to their immune system.
  • The patient must have a measurable disease that shows up on specific imaging tests like PET scans or MRI, which are used to see how the disease is responding to treatment.
  • The patient must have previously tried a treatment called **rituximab** (or a similar drug) and it did not work, or they had a relapse after treatment. This applies to those who had a solid organ transplant or a bone marrow transplant.
  • Both males and females of any age can participate.
  • For patients aged 16 and older, they must have a performance status of 3 or less, which is a measure of their ability to perform daily activities. For those under 16, they must have a Lansky score of 20 or more, which is a similar measure for children.
  • For patients who had a bone marrow transplant due to certain blood cancers, their original disease must be in remission, meaning it is not currently active.
  • The patient must have adequate organ function, which includes:
    • A certain level of white blood cells called neutrophils, which help fight infection.
    • A certain level of platelets, which help with blood clotting.
    • Liver function tests (ALT, AST, and bilirubin) must be within acceptable limits, unless the doctor believes the liver issues are due to the disease being studied.

Who cannot join the trial?

5 criteria

  • Patients who have not experienced failure of previous treatments like rituximab or chemotherapy. Rituximab is a medication used to treat certain types of diseases, including some cancers.
  • Patients who have not undergone a solid organ transplant or allogeneic hematopoietic cell transplant. A solid organ transplant involves replacing a failing organ, like a kidney or liver, with a healthy one from a donor. An allogeneic hematopoietic cell transplant is a procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who are not part of the specific groups being studied, such as those who have not received a commercial product or a similar treatment process.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet other specific health criteria required for the study.
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Investigated drugs

  • Tabelecleucel (ATA129)

    is a type of therapy that uses special immune cells called T cells. These T cells are designed to target and destroy cells infected with the Epstein-Barr virus (EBV). This therapy is being studied for patients who have developed a condition called post-transplant lymphoproliferative disease (PTLD) after receiving a solid organ or bone marrow transplant. The goal is to see if these specially prepared T cells can help control or eliminate the disease when other treatments, like rituximab or chemotherapy, have not worked.

  • Rituximab

    is a medication that is often used to treat certain types of cancer and autoimmune diseases. It works by targeting a specific protein found on the surface of certain immune cells, leading to their destruction. In this study, rituximab is used as a previous treatment for patients with post-transplant lymphoproliferative disease, and the trial is looking at patients for whom rituximab alone or in combination with chemotherapy did not succeed.

  • Chemotherapy

    refers to a group of medications that are used to kill or stop the growth of cancer cells. In this trial, chemotherapy is used in combination with rituximab for some patients. The study is focused on patients who did not respond to this combination treatment, exploring whether tabelecleucel can provide additional benefits.

What is already known about the treatment

Tabelecleucel – Tabelecleucel is administered through an intravenous infusion, targeting Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease, particularly after the failure of treatments like rituximab or rituximab combined with chemotherapy. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness in patients who have undergone solid organ or allogeneic hematopoietic cell transplants. The medication works by using specially prepared T cells that are designed to recognize and attack cells infected with the Epstein-Barr virus. Tabelecleucel is classified as an immunotherapy, specifically utilizing allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes to combat the disease.

Investigated diseases

Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease – This disease occurs in individuals who have undergone organ or stem cell transplants and is linked to the Epstein-Barr virus. It involves the abnormal growth of lymphoid cells, which are a type of white blood cell. The disease can manifest in various forms, ranging from benign growths to aggressive lymphomas. It typically develops due to the immunosuppressive medications used to prevent transplant rejection, which can allow the Epstein-Barr virus to reactivate. Symptoms may include fever, swollen lymph nodes, and organ dysfunction. The progression of the disease can vary, with some cases resolving spontaneously while others may require medical intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516622-57-00Protocol codeATA129-EBV-302Estimated enrolment74 patientsSponsorPierre Fabre Medicament

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).