A Phase 1/2 interventional study of Group A and Group B in Epstein-Barr Virus Infections, Post-Transplant Lymphoproliferative Disorder and Lymphoma, sponsored by Dr. Jean-Sebastien Delisle, MD, PhD. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Dr. Jean-Sebastien Delisle, MD, PhD · Phase 1/2, Interventional, and Treatment
This study evaluates the safety and efficacy of EBV-specific T-cell lines to treat patients suffering from high EBV viral titers not responding to standard of care therapies and to treat EBV-related lymphoma. The study will recruit 6 patients to receive autologous T cells or a T cell line derived from the patient's allogeneic donor (in the case of stem cell transplant recipients), and 6 patients to receive a T-cell line prepared from a matched or partially matched related donor.
Epstein-Barr virus (EBV) is a member of the herpes virus family and infects up to 95% of individuals over their lifetime. Most initial infections occur in childhood and after a brief flu-like illness, the virus enters a phase of latency.
Patients who receive a bone marrow transplant or an organ transplant take medications drugs that weaken their immune systems. In these contexts, the virus can "reactivate" and cause very serious problems, such as lymphoma. For unknown reasons, people with a normal immune system can also develop lymphoma due to EBV.
The purpose of this study is to test the safety and efficacy of immune cells (T lymphocytes) that are specifically "taught" to recognize the virus-infected cells and to eliminate them. This "education" occurs is done over during a 2 weeks period (approximately), in the research laboratory. The cells are then transfused into the patient.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 12 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Dr. Jean-Sebastien Delisle, MD, PhD as lead sponsor.
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Exclusion Criteria:
DONOR ELIGIBILITY: An allogeneic donor must be a first-degree relative with at least 3/6 HLA compatibility, have consented to donate peripheral blood mononuclear cells, and fulfill the same criteria for stem cell donation according to the hospital's standard operating procedure.
Subjects receive an autologous anti-EBV T-cell line or a T-cell line derived from the patient's allogeneic (stem cell transplant) donor.
Biological: Group A
Subjects receive a T-cell line from a matched or partially matched related donor.
Biological: Group B
Peptide-stimulated T cells 2 x 10\^7/m\^2
Peptide-stimulated T cells per dose-escalation protocol
Safety: Incidence and description of CTCAE v.4.03 adverse events related to the experimental treatment
Complications: infusional toxicity, immune-related and other
Time frame: During observation period (up to 42 days post infusion)
Changes in EBV titers (viral load) for each patient
As measured by PCR weekly until week 6, at 3 months, 6 months and 12 months
Time frame: Until 12 months post infusion
Immune reconstitution as measured by various laboratory assays of immune cell type and function
ELISpot on peripheral blood is assessed at the time points mentioned above
Time frame: During observation period until 12 months post infusion
All cause mortality
Within the 12 months observation period
Time frame: At 12 months
Transplant-related outcomes
Incidence/severity of graft-versus-host disease, solid organ rejection episodes, relapse
Time frame: During observation period until 12 months post infusion
Incidence/severity of graft-versus-host disease among patients who underwent stem cell transplantation
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Time frame: During observation period until 12 months post infusion
Number and severity of solid organ rejection episodes per patient among those who underwent solid organ transplant
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Time frame: During observation period until 12 months post infusion
Incidence of primary disease relapse among patients who underwent stem cell transplantation
Based on standardized assessments done weekly until week 6 and at 3, 6 and 12 months
Time frame: During observation period until 12 months post infusion
Malignancy staging for patients with lymphoma, per internationally-accepted guidelines for the different specific lymphomas
As clinically indicated by the investigators and/or primary physician
Time frame: During observation period until 12 months post infusion
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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