Phase 1 Study of Donor-Derived EBV-TCR-T Cell Therapy for Treating EBV Infection After Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are evaluating EBV-TCR-T cell immunotherapy as a treatment for Epstein-Barr virus EBV infection occurring after allogeneic hematopoietic stem cell transplantation HSCT. This is a phase 1, multi-center, open-label study focused on assessing the safety and effectiveness of this therapy in patients with hematologic malignancies who develop EBV infection following HSCT. The study aims to provide important information on how this treatment works and its potential risks. Patients will receive one to three infusions of EBV-specific T cell receptor TCR T cells derived from their HSCT donors. These EBV-TCR-T cells are created by introducing a specific TCR into donor T cells through lentiviral transduction. The infused doses will escalate from 5105kg up to 1106kg. A second phase will adjust dosing based on pharmacokinetics and patient response data. This therapy is delivered intravenously and closely monitored. Participants will be followed for up to one year after treatment, during which researchers will monitor adverse events, changes in EBV-DNA levels, persistence of the infused cells, and cytokine concentrations. Dose-limiting toxicities and maximum tolerated doses will also be evaluated within the first 28 days. Additional outcomes include response rates, duration of response, incidence of EBV-related complications, and pharmacokinetic parameters of the therapy. Safety and effectiveness assessments will involve laboratory tests, clinical evaluations, and follow-ups throughout the study period.

Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT