NCT06391814

Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Ciusss de L'Est de l'Île de Montréal · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood.

Detailed description

Following a presumed primary EBV infection, a 19 year old female patient rapidly suffered systemic inflammatory response, hemophagocytosis, multi-organ failure and evidence of EBV+ T-cell lymphoma. The patient was aggressively treated and responded to SMILE-based chemotherapy. Once complete response was ascertained by PET imaging, the patient underwent myeloablative HLA-matched unrelated allogeneic stem cell transplantation (cyclophosphamide 60mg/Kg, total body irradiation - 12Gy with anti-thymocyte globulin). The stem cell donor had a positive serology for EBV (IgG). The patient's EBV titer was weakly positive at the time of transplantation. A decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded EBV-reactive T cells following transplantation. A EBV-specific T-cell line was manufactured from a portion of the cryopreserved G-CSF mobilized peripheral graft after appropriate authorizations were obtained. The patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of EBV-reactive T cells (20x10e6 T cells/meter square of body surface area 5 months post-transplantation

Conditions

• EBV Associated Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	EBV-specific T cells	Consolidative cellular immunotherapy consisting of one (or up to 4) infusion of ex vivo expanded T cells

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-04-05
• Completion: 2025-04-05
• First posted: 2024-04-30
• Last updated: 2026-03-23

Locations

1 site across 1 country: Canada