Award
Food and Drug Administration 3R01FD007837-02S1
A Randomized Study of Maternal Donor Derived CMV Cytotoxic T-Lymphocytes (CTLs) and Valganciclovir vs Valganciclovir in Neonates With Moderate/Severe Maternal Acquired CMV Infection
Recipient
New York Medical College, Valhalla, NY, United States
Award Amount
$324,998.00
Ceiling
$324,998.00
Awarded
June 25, 2026
Identifier
3R01FD007837-02S1
A study funded by the FDA to assess the safety and efficacy of maternal donor-derived CMV-specific cytotoxic T-lymphocytes combined with valganciclovir in neonates with moderate/severe maternal acquired CMV infection, aiming to improve long-term neurological outcomes.
Description
This project aims to evaluate the safety and efficacy of maternal-derived CMV-specific cytotoxic T-lymphocytes in neonates with CMV infection, potentially providing a novel therapeutic approach to a significant unmet medical need. The study involves manufacturing maternal donor-derived CMV CTLs under GMP conditions, administering doses every 2 weeks up to 5 doses, combined with a 6-month course of valganciclovir or placebo, and performing genomic and immunomic studies along with long-term neurological outcome assessments.