Phase 1 Study of Rapidly Generated Virus Specific T Cells R-MVST for Treating Viral Infections in Immunodeficient Children and Young Adults

What this Trial Is About

This research aims to evaluate the safety and feasibility of giving rapidly generated virus specific T R-MVST cells to patients with difficult-to-treat viral infections caused by Epstein Barr Virus EBV, cytomegalovirus CMV, adenovirus ADV, or BK virus. These viruses can reactivate and cause serious illness in people with weakened immune systems, such as those who have had stem cell or organ transplants or other immune system problems. The study is a Phase 1, non-randomized, open-label dose escalation trial enrolling children and young adults with immune deficiencies. Participants are divided into three groups based on their immune status those who received allogeneic stem cell transplants, those with solid organ transplants, and those with other reasons for immune suppression. R-MVST cells are made from the closest partially matched healthy donor or original transplant donor. Different dose levels will be tested in each group to find the best balance of safety and potential effectiveness. During the study, participants will receive the R-MVST cell infusion and be closely monitored for side effects such as graft-versus-host disease GVHD for up to 28 days after infusion. Researchers will also track viral load, immune recovery, clinical responses, overall survival, and possible secondary graft failure for up to one year after treatment. The study lasts from screening through follow-up, with ongoing evaluations to assess treatment impact and safety.

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults