This phase II trial studies how well donor cytomegalovirus-specific cytotoxic T-lymphocytes work in treating patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy. White blood cells from donors who have been exposed to cytomegalovirus may be effective in treating patients with a cytomegalovirus infection.
Additional locations may be listed on ClinicalTrials.gov for NCT02210078.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched cytomegalovirus (CMV) specific cytotoxic T-lymphocytes (HMC-CTLs) generated by “gamma-catch” to mediate antiviral activity in hematopoietic stem cell transplantation (HSCT) recipients with CMV infections.
SECONDARY OBJECTIVE:
I. To assess the persistency of the administered HMC-CTLs generated by “gamma-catch” and their contribution immune reconstitution.
OUTLINE:
Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes intravenously (IV). Patients with partial response, stable disease, or progressive disease may receive an additional dose of allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes at a minimum of 2 weeks from the first infusion. Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up periodically for 12 months.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBetul Oran