Phase 1 Study of Rapidly Generated Virus Specific T Cells to Treat Viral Infections in Patients With Immune System Problems

What this Trial Is About

Researchers are evaluating the safety and feasibility of using rapidly generated virus specific T R-MVST cells to treat patients with difficult-to-manage viral infections caused by Epstein-Barr Virus EBV, cytomegalovirus CMV, adenovirus ADV, or BK virus. These infections often reactivate in patients with weakened immune systems, such as those who have received stem cell or solid organ transplants or those with immune-suppressing conditions. The study aims to monitor for potential toxicities, including graft-versus-host disease GVHD, and assess the impact of R-MVST cell infusion on viral load, immune recovery, clinical responses, and overall survival. Participants will receive R-MVST cells generated from the closest partially matched healthy donor or from the original transplant donor when available. Two groups are studied Group A includes stem cell transplant recipients receiving lower doses due to higher GVHD risk, and Group B includes solid organ transplant recipients receiving higher doses. Each participant will receive a single dose initially, followed by close monitoring for 28 days for toxicity and GVHD. Up to two additional doses may be given at least 28 days apart if safety criteria are met, with each infusion followed by another 28-day safety monitoring period. Participants will be observed for virological and clinical responses for up to one year after the first infusion. Throughout the study, participants will be closely monitored for safety through evaluations of toxicity and GVHD up to 28 days after each infusion. Viral load, organ function, and overall survival will be assessed for up to one year following the initial treatment. Secondary graft failure will be checked 28 days after infusion. Safety and response monitoring include clinical assessments and laboratory tests. The entire participation period may last up to one year, with regular follow-up visits to track treatment effects and any adverse events.

R-MVST Cells for Treatment of Viral Infections