drugset / Trial / NCT05564598
CMV CTLs in Neonates With CMV Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |