Using donor-derived T cells to treat life-threatening EBV lymphoma
Open-Label Individual Patient Study of Epstein-Barr Virus (EBV) Specific T-Cell Lines for the Treatment of a Lymphoproliferative Disease and Hemophagocytic Syndrome Associated With EBV
This study is testing if using special immune cells from a donor can help a young adult with a serious EBV lymphoma stay in remission after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Sex | Female |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT06391814 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on a single patient who is a young adult suffering from systemic EBV-positive lymphoma following a primary EBV infection. After undergoing aggressive chemotherapy and allogeneic stem cell transplantation, the patient will receive a treatment involving donor-derived EBV-specific T cells to consolidate their remission. The T cells are manufactured from the donor's peripheral graft and administered five months post-transplantation to target any residual EBV-positive lymphoma cells. This approach aims to enhance the patient's immune response against the lymphoma.
Who should consider this trial
Good fit: Ideal candidates for this study are young adults aged 18 and older who have undergone allogeneic stem cell transplantation for EBV-positive lymphoma.
Not a fit: Patients with active uncontrolled graft-versus-host disease or those who have recently received T-cell depleting antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel immunological consolidation strategy for patients with EBV-associated lymphomas.
How similar studies have performed: While this approach is innovative, similar studies using adoptive immunotherapy for EBV-related conditions have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Capacity to provide informed consent 2. Age ≥ 18 3. Negative serum pregnancy test and use of effective contraception method. Exclusion Criteria: 1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath) 2. Pregnancy 3. Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome. 4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion.
Where this trial is running
Montréal, Quebec
- Ciusss-Emtl — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Jean-Sébastien Delisle, MD, PhD
- Email: js.delisle@umontreal.ca
- Phone: 514-252-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.