Early Phase 1 Study of CMV-Specific T Cell Therapy to Treat Cytomegalovirus Infection After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the feasibility of a cell-based immunotherapy using donor T-cells that specifically target cytomegalovirus CMV infections occurring after hematopoietic stem cell transplant HSCT. This investigational approach, called adoptive T-cell therapy, aims to help the immune system fight CMV by infusing virus-specific T-cells selected with the CliniMACS Prodigy System. The study also seeks to describe the safety and potential toxicities of this therapy as well as its ability to eradicate CMV infections. Participants will receive a one-time infusion of CMV-specific adoptive T-cells, with the expected dose ranging from 103 to 105 selected T-cells per kilogram of recipient weight. After the infusion, patients will be observed for 4 weeks to assess treatment effects and safety. This study includes a single treatment group and focuses on early-phase evaluation of this experimental biological therapy. During the study, participants will be monitored for adverse events up to 100 days after transplant, along with assessments of CMV infection eradication and response rates. Researchers will collect data on safety and treatment outcomes during follow-up. Participants will undergo evaluations including clinical assessments and laboratory monitoring to track immune response and infection status throughout the study period.

T Cell Therapy of Opportunistic Cytomegalovirus Infection