Pilot Study of CMV Specific Cytotoxic T-Cells to Treat Refractory Cytomegalovirus Infections in Children, Adolescents, and Young Adults After Transplant

What this Trial Is About

Researchers are evaluating virus specific cytotoxic T-lymphocytes CTLs for children, adolescents, and young adults with refractory cytomegalovirus CMV infection after allogeneic hematopoietic stem cell transplantation, primary immunodeficiencies, or solid organ transplant. This phase 2 pilot study aims to assess the safety, tolerability, and response to treatment of CMV specific CTLs manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System. The study is sponsored by New York Medical College and funded by the FDA OOPD. Participants will receive one dose of CMV specific CTLs derived from HLA matched or mismatched donors. HLA matched donors receive 2.5 x 104 CD3 cells per kg of recipient weight, while HLA mismatched donors receive 0.5 x 104 CD3 cells per kg. If there is no viral load reduction after the first dose, up to five total doses may be administered. The CTLs are collected, manufactured in a GMP facility, and given to patients with refractory CMV infection. During the study, patients will be followed for 12 weeks after each infusion to monitor treatment-emergent side effects and response to therapy. Researchers will assess safety, tolerability, and changes in viral load. Participants must provide informed consent and comply with study procedures, including donor disease screening and performance status assessments. The total participation duration and monitoring extend through the follow-up period after each infusion.

Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)