drugset / Trial / NCT05564598

CMV CTLs in Neonates With CMV Infection

NCT05564598

Phase 2 Recruiting 23 enrolled New York Medical College
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2023-07-01
Primary completion
2027-10-31
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CMV Cytotoxic T-Lymphocytes Cell therapy 25000 cells/kg
Background Ganciclovir Small molecule 6 mg/kg Intravenous
Background Valganciclovir Small molecule 16 mg/kg Oral