Pilot Study of Related Donor Adenovirus-Specific Cytotoxic T-Lymphocytes for Treating Refractory Adenovirus Infection in Children, Adolescents, and Young Adults After Stem Cell or Organ Transplant

What this Trial Is About

This clinical trial focuses on children, adolescents, and young adults who have refractory adenovirus infection following allogeneic hematopoietic stem cell transplantation, primary immunodeficiencies, or solid organ transplant. The study evaluates related donor adenovirus-specific cytotoxic T cells CTLs produced using the Miltenyi CliniMACS Prodigy Cytokine Capture System. The goal is to assess the safety, tolerability, and response to these CTLs in treating difficult adenovirus infections. Participants will receive an intravenous infusion of adenovirus-specific cytotoxic T-lymphocytes. The dose differs based on donor match 2.5 x 104 CD3kg for matched related donors and 0.5 x 104 CD3kg for mismatched related donors. If patients do not respond to the first infusion, they may receive up to five total CTL infusions. The study includes a follow-up period to monitor the effects of each infusion. During the study, participants will be closely monitored for treatment-emergent adverse events and their response to treatment over 12 weeks after each infusion. Assessments include clinical evaluations and laboratory tests to measure adenovirus levels and immune response. Safety and efficacy are the primary focus, with ongoing observation through the study period. The total duration of participation varies depending on response and number of infusions received.

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection