Award
Food and Drug Administration 5R01FD007837-02
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
Award Amount
$324,998.00
Ceiling
$324,998.00
Awarded
September 02, 2025
Identifier
5R01FD007837-02
This award funds a clinical trial by New York Medical College to study maternal donor-derived CMV cytotoxic T-lymphocytes and Valganciclovir treatment in neonates with moderate/severe maternal acquired CMV infection, focusing on safety and efficacy.
Description
The project involves a clinical trial to evaluate maternal donor-derived CMV cytotoxic T-lymphocytes in neonates. The project aims to assess safety, efficacy, immune signatures, and long-term outcomes. The project is conducted by New York Medical College in Valhalla, NY under an FDA orphan grant program.