Ongoing Clinical Trials for Epstein-Barr Virus Associated Lymphoproliferative Disorder
There are currently 2 clinical trials underway investigating treatments for Epstein-Barr virus associated lymphoproliferative disorder. These studies are evaluating a cell therapy called tabelecleucel for patients who have not responded to standard treatments or for whom conventional therapies are not suitable. Trials are being conducted across multiple European countries including Austria, Belgium, France, Italy, and Spain.
Clinical trial locations
- Austria
- Belgium
- France
- Italy
- Spain
Study of Tabelecleucel for Patients with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Transplant Treatment Failure
This Phase 3 clinical trial is investigating a cell therapy treatment for patients who develop lymphoproliferative disease after receiving an organ or stem cell transplant. The condition, which is linked to the Epstein-Barr virus, can occur when patients take medications to prevent transplant rejection, as these drugs weaken the immune system and may allow the virus to become active again.
Main inclusion criteria: The study is open to patients of any age who have received either a solid organ transplant (such as kidney, liver, heart, lung, pancreas, or small bowel) or a bone marrow transplant. Participants must have a confirmed diagnosis of Epstein-Barr virus-associated post-transplant lymphoproliferative disease with measurable signs of the condition visible on imaging tests such as PET scans or MRI. Importantly, patients must have previously tried treatment with rituximab (or a similar medication) either alone or combined with chemotherapy, and these treatments must not have worked or the disease must have returned. Participants need to have adequate organ function, including acceptable levels of white blood cells, platelets, and liver function tests, unless these are affected by the disease itself. For adults and older teens, a performance status of 3 or less is required, while younger children need a Lansky score of 20 or more, which measure the ability to perform daily activities.
Main exclusion criteria: Patients who have not previously tried and failed treatment with rituximab or chemotherapy cannot participate. The study also excludes those who have not undergone either a solid organ transplant or a bone marrow transplant. Patients who fall outside the specific age ranges or do not meet other required health criteria are also not eligible.
Trial focus and goals: The main goal of this study is to evaluate whether tabelecleucel can provide clinical benefit to patients whose disease has not responded to standard treatments. Researchers will measure the objective response rate, which means they will assess how many patients experience improvement in their condition. The study will also track how long responses last, overall survival rates, and how long patients live without their disease worsening. Participants will receive tabelecleucel through intravenous infusion, and regular monitoring using imaging tests will assess how well the treatment is working.
Investigational drug: Tabelecleucel, also known as ATA129, is a specialized immunotherapy that uses specially prepared T cells designed to recognize and attack cells infected with the Epstein-Barr virus. These immune cells are collected, prepared in a laboratory, and then given to patients through injection into a vein. The therapy aims to target and destroy the virus-infected cells that are causing the lymphoproliferative disease. The study is also examining the use of rituximab and chemotherapy as previous treatments that patients have received before entering the trial.
Study on Tabelecleucel for Patients with Epstein-Barr Virus-Associated Diseases
This Phase 2 clinical trial is studying the effectiveness of a cell therapy treatment for several different types of Epstein-Barr virus-associated diseases. These include lymphoproliferative disorders affecting the brain and spinal cord, diseases occurring in patients with weakened immune systems from birth or acquired conditions, and rare tumors such as leiomyosarcoma or smooth muscle tumors. The study also includes patients for whom standard treatments like rituximab or chemotherapy are not appropriate options.
Main inclusion criteria: This study accepts patients of any age, both male and female. Participants must have an Epstein-Barr virus-associated condition that has been confirmed through a tissue biopsy, meaning a small sample has been tested and proven to contain the virus. The disease must be measurable on imaging tests such as CT or MRI scans. Patients must have adequate organ function unless the disease itself is affecting organ performance. Participants should have either tried standard treatments that did not work, have disease that has returned after treatment, or have a newly diagnosed condition where standard treatment is not suitable. For certain conditions involving the brain and spinal cord, evidence of disease must be confirmed through examination of the fluid surrounding the brain and spine. Written consent to participate is required, and for younger patients, assent from a guardian may also be needed.
Main exclusion criteria: The study specifically focuses on patients with post-transplant lymphoproliferative disease affecting the central nervous system, primary immunodeficiency-related disease, lymphoproliferative disease in patients with acquired immune system weakness, Epstein-Barr virus-associated sarcomas, and cases where standard first-line therapies are not appropriate, including disease that lacks the CD20 protein marker.
Trial focus and goals: The primary aim of this trial is to determine whether tabelecleucel can provide meaningful clinical benefit across several different types of Epstein-Barr virus-associated diseases. Researchers will measure the objective response rate to see how many patients experience improvement. The study will also evaluate how long responses last, overall survival rates, and progression-free survival, which measures how long patients live without their disease getting worse. Throughout the study, participants will undergo regular monitoring with imaging tests and laboratory evaluations to track disease progression and treatment response.
Investigational drug: Tabelecleucel is an immunotherapy that uses specialized T cells targeting the Epstein-Barr virus. These immune cells are designed to identify and destroy cells infected with the virus. The therapy is administered through intravenous infusion, with the specific dosage and frequency determined by the study protocol and the healthcare team overseeing treatment. This approach aims to enhance the body’s own immune response to fight the virus-related conditions.
Summary
Both ongoing clinical trials are investigating the same investigational therapy, tabelecleucel, for different presentations of Epstein-Barr virus-associated lymphoproliferative disorders. The first trial focuses specifically on post-transplant disease in patients who have failed rituximab or chemotherapy, while the second trial covers a broader range of conditions including central nervous system involvement, primary and acquired immunodeficiency-related disease, and rare sarcomas.
Geographically, both studies are being conducted across the same five European countries: Austria, Belgium, France, Italy, and Spain. This concentration of trials in Western European nations may reflect the expertise and infrastructure available in these regions for conducting complex immunotherapy studies. The trials are expected to run until 2026 and 2027 respectively, allowing researchers sufficient time to gather comprehensive data on this novel cell-based therapy approach for virus-associated cancers.
