CMV CTLs in Neonates With CMV Infection

Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs. Funding source: FDA OOPD

NCT Number	NCT05564598
Lead Sponsor	New York Medical College
Conditions	Congenital Cytomegaloviral (CMV) Disease
Enrollment	23 participants
Start Date	2023-07-01
Primary Completion	2027-10-31 (estimated)
Study Completion	2028-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-30