Pilot Study of Donor-Derived Virus-Specific T Cell Therapy to Treat Cytomegalovirus or Adenovirus Reactivation After Stem Cell or Solid Organ Transplant

What this Trial Is About

Researchers are evaluating the safety and feasibility of using donor-derived virus-specific cytotoxic T lymphocytes CTLs to treat cytomegalovirus CMV or adenovirus AdV infections or reactivations in patients who have received either a solid organ transplant or a hematopoietic stem cell transplant. This early phase 1 trial aims to understand how well these specialized immune cells work against viral infections that persist despite standard treatments, providing a potential new approach for transplant recipients facing these complications. Participants are assigned to one of two groups based on their viral infection. One group receives allogeneic CMV-specific CTLs, and the other receives allogeneic AdV-specific CTLs, both given intravenously. If an infection persists after the initial infusion, a second dose may be administered after 28 days. Throughout the study, samples including blood, urine, saliva, cerebrospinal fluid, and lung fluid are collected for monitoring. After treatment, participants are followed for one year to assess outcomes. During the trial, participants undergo regular evaluations to monitor side effects, viral load responses, and the persistence of infused CTLs. Researchers track adverse events up to 30 days post-infusion and follow feasibility measures, including donor availability and T cell dose success, for up to one year. Secondary assessments include survival, risks of graft-versus-host disease, infection rates, and clinical responses to treatment. The total involvement includes treatment infusions and a one-year follow-up period to gather comprehensive safety and effectiveness data.

Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT