Study of EBV-TCR-T Cell Therapy for Epstein-Barr Virus DNAemia After Stem Cell Transplant

What this Trial Is About

Researchers are studying patients who have Epstein-Barr virus EBV DNAemia after receiving allogeneic hematopoietic stem cell transplantation allo-HSCT. This condition can lead to serious complications like EBV-associated lymphoproliferative disorders. The study aims to explore the safety, tolerability, and early effects of a new immune-based therapy using EBV-specific T cell receptor-engineered T cells EBV-TCR-T cells to target and eliminate EBV-infected cells. Participants will receive intravenous infusions of EBV-TCR-T cells, which are genetically engineered T lymphocytes designed to recognize EBV antigens. The treatment involves up to three weekly infusions on Day 0, Day 7, and Day 14, with dose levels increasing from 1105 to 1106 cellskg. The study will follow a dose-escalation design to determine the maximum tolerated dose and optimal biologic dose. During the study, participants will be monitored for safety and immune response for up to 12 months after the first infusion. Researchers will assess adverse events, the clearance of EBV DNA, changes in viral load, and how the infused cells expand and persist in the body. These evaluations include pharmacokinetic and pharmacodynamic analyses, with long-term safety follow-up as specified in the protocol.

Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation