Award
NIH Reporter #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
Mitchell S. Cairo
Award Amount
$324,998.00
Ceiling
$324,998.00
Awarded
June 25, 2026
Identifier
3R01FD007837-02S1
The award funds a randomized study to evaluate maternal donor-derived CMV cytotoxic T-lymphocytes combined with valganciclovir versus valganciclovir alone in neonates with moderate/severe maternal acquired CMV infection, focusing on safety, efficacy, immune response, and long-term neurological outcomes.
Description
This project involves manufacturing and administering maternal donor-derived CMV cytotoxic T-lymphocytes in neonates, with extensive genomic and immunomic analysis, and long-term neurological follow-up. The study aims to determine feasibility, safety, and efficacy of maternal donor-derived CMV specific CTLs with standard of care versus standard of care alone, characterize genomic and immunomic signatures, and quantify long-term neurological sequelae and developmental disabilities.