Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on Tabelecleucel for Patients with Epstein-Barr Virus-Associated Diseases

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying diseases associated with the Epstein-Barr Virus (EBV). These diseases include EBV-associated post-transplant lymphoproliferative disorder (PTLD), which can affect the central nervous system, EBV-associated primary immunodeficiency lymphoproliferative disease (LPD), and EBV-associated sarcomas, such as leiomyosarcoma or smooth muscle tumors. The trial also includes cases where standard treatments like rituximab or chemotherapy are not suitable. The treatment being tested is 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 diseases.

The purpose of this study is to evaluate the benefits of using tabelecleucel in patients with these EBV-associated diseases. Participants in the study will receive tabelecleucel through an injection into a vein. The study will monitor how well the treatment works and its safety over a period of time. The study is designed to see how many patients respond to the treatment and how long the response lasts. It will also look at overall survival rates and how long patients live without the disease getting worse.

The study will follow participants to gather information on the effectiveness of tabelecleucel in treating these conditions. The goal is to determine if this treatment can provide a clinical benefit to patients with EBV-associated diseases. The study will continue until the estimated end date in 2026, with the aim of collecting comprehensive data on the treatment's impact on these serious conditions.

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 specific criteria related to the condition associated with the Epstein-Barr Virus (EBV).

    The study is designed for individuals with EBV-associated diseases, such as certain types of lymphoproliferative disorders and sarcomas.

  2. Step 2

    Treatment initiation

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

    Tabelecleucel is given through an intravenous route, meaning it is injected directly into a vein.

  3. Step 3

    Treatment schedule

    The specific dosage and frequency of tabelecleucel administration are determined by the study protocol and the healthcare provider overseeing the treatment.

    The treatment aims to assess the clinical benefit by measuring the objective response rate (ORR) in patients.

  4. Step 4

    Monitoring and assessment

    Throughout the study, regular monitoring is conducted to evaluate the response to the treatment and any potential side effects.

    Assessments may include imaging tests and laboratory evaluations to measure disease progression and response.

  5. Step 5

    Completion of treatment

    The study is expected to continue until July 31, 2026, with the duration of individual participation varying based on response and other factors.

    Upon completion, the overall survival, duration of response, and progression-free survival are evaluated as part of the study's secondary endpoints.

Who can join the trial?

10 criteria

  • Patients of any age, both males and females, can participate.
  • Must have a condition related to **EBV** (Epstein-Barr Virus), such as certain types of cancers or diseases affecting the immune system.
  • Must have a **biopsy-proven** condition, meaning a small sample of tissue has been tested and confirmed to have EBV.
  • Must have **measurable disease**, which means the disease can be seen and measured using imaging tests like CT or MRI scans.
  • Must have **adequate organ function**, meaning the organs are working well enough, unless the disease is affecting them.
  • Must have tried standard treatments like **rituximab** or chemotherapy, and these treatments are not suitable or have not worked.
  • Must have a **relapsed** (came back) or **refractory** (did not respond) disease, or a newly diagnosed condition where standard treatment is not appropriate.
  • Must have provided written consent to participate in the study, and if underage, assent from a guardian if required by law.
  • For certain conditions, must have evidence of disease in the **central nervous system** (CNS), which includes the brain and spinal cord, confirmed by tests like **CSF cytology** (examining the fluid around the brain and spine).
  • For some conditions, must have **systemic disease**, meaning the disease affects the whole body, confirmed by specific imaging tests.

Who cannot join the trial?

5 criteria

  • Patients with a type of cancer called EBV+ associated post-transplant LPD that affects the brain and spinal cord, known as the central nervous system.
  • Patients with EBV+ primary immunodeficiency lymphoproliferative disease, which is a condition where the immune system is not working properly from birth.
  • Patients with EBV+ associated lymphoproliferative disease that occurs due to a weakened immune system that is not present from birth.
  • Patients with EBV+ sarcomas, which are a type of cancer that includes leiomyosarcoma or tumors of the smooth muscle.
  • Patients with EBV+ post-transplant LPD where the usual first treatment, like rituximab or chemotherapy, is not suitable, including cases where the disease does not have a protein called CD20.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tabelecleucel 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 to see if it can help people with diseases related to EBV by improving their condition.

What is already known about the treatment

Tabelecleucel – Tabelecleucel is administered as an infusion, targeting Epstein-Barr virus (EBV)-associated diseases. It is currently being studied in clinical trials, specifically in a Phase 2 study, to evaluate its effectiveness and safety. The main therapeutic indications include EBV-associated post-transplant lymphoproliferative disorders (LPD), primary immunodeficiency LPD, and EBV-associated sarcomas. Tabelecleucel works by using allogeneic EBV-specific cytotoxic T lymphocytes to target and destroy EBV-infected cells. It is classified as an immunotherapy, focusing on enhancing the body's immune response to fight EBV-related conditions.

Investigated diseases

  • EBV+ associated post-transplant lymphoproliferative disorder involving the central nervous system (EBV+ CNS PTLD)

    This disease occurs when abnormal growth of lymphoid cells happens in the central nervous system after a transplant, often due to Epstein-Barr virus (EBV) infection. It typically develops in individuals with weakened immune systems, such as those who have undergone organ transplants. The disease can lead to neurological symptoms as it affects the brain and spinal cord. Over time, it may cause cognitive and motor function impairments. The progression can vary, with some cases remaining stable while others may worsen.

  • EBV+ primary immunodeficiency lymphoproliferative disease (LPD)

    This condition arises in individuals with primary immunodeficiency, where the immune system is inherently weak, leading to uncontrolled growth of lymphoid cells due to EBV infection. It can manifest with symptoms like swollen lymph nodes, fever, and fatigue. The disease may progress with the development of tumors or other complications. The severity and progression can differ based on the underlying immune deficiency and the body's response to the virus.

  • EBV+ associated lymphoproliferative disease in the setting of acquired (non-congenital) immunodeficiency (EBV+ AID LPD)

    This disease occurs in individuals who have acquired immunodeficiency, such as from HIV infection or immunosuppressive therapy, leading to abnormal lymphoid cell growth due to EBV. Symptoms can include fever, weight loss, and enlarged lymph nodes. The disease may progress with the potential for organ involvement and further immune system compromise. The course of the disease can vary depending on the level of immunosuppression and viral activity.

  • EBV+ sarcomas, including leiomyosarcoma, or smooth muscle tumors

    These are rare tumors associated with EBV infection, affecting smooth muscle tissues such as those in the gastrointestinal tract or blood vessels. They can present as masses or lumps and may cause pain or obstruction depending on their location. The progression of these tumors can vary, with some growing slowly while others may be more aggressive. The disease can lead to complications based on the size and location of the tumors.

  • EBV+ post-transplant lymphoproliferative disorder where standard first-line therapy is inappropriate, including CD20-negative disease

    This condition occurs when lymphoid cells grow uncontrollably after a transplant, and standard treatments like rituximab or chemotherapy are not suitable, often due to the absence of CD20 markers. It can present with symptoms such as fever, weight loss, and swollen lymph nodes. The disease may progress with potential organ involvement and further immune system compromise. The progression can vary, with some cases remaining stable while others may worsen.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516623-14-00Protocol codeATA129-EBV-205Estimated enrolment176 patientsSponsorPierre Fabre Medicament

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.