Pilot Study of Related Donor EBV-Specific Cytotoxic T-Lymphocytes for Treating Refractory Epstein-Barr Virus Infection in Children, Adolescents, and Young Adults

What this Trial Is About

Researchers are evaluating related donor Epstein-Barr Virus EBV specific cytotoxic T cells CTLs in children, adolescents, and young adults who have refractory EBV infection after Allogeneic Hematopoietic Stem Cell Transplantation AlloHSCT, have primary immunodeficiencies, or are post solid organ transplant recipients. This pilot study is sponsored by New York Medical College and funded by the FDA Office of Orphan Products Development to assess the safety and effectiveness of these CTLs in managing difficult EBV infections. Participants receive one dose of EBV-specific CTLs produced using the Miltenyi CliniMACS Prodigy Cytokine Capture System from related donors. If the patient does not respond based on EBV PCR tests, they may receive up to four additional doses, for a maximum of five doses. The CTLs are generated from HLA-related matched or mismatched donors in a specialized facility and administered under medical supervision. During the study, patients are monitored for treatment-emergent adverse events and response to treatment for 12 weeks following each infusion. Researchers will perform various assessments including EBV PCR testing to evaluate viral levels and clinical symptoms. The total participation duration depends on the number of infusions received, with close follow-up to track safety and efficacy outcomes throughout the trial period ending in December 2027.

EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection