Mother-derived CMV immune cells plus antiviral medicine for newborns with moderate-to-severe congenital CMV
Official title: 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
Funded at New York Medical College · NIH-10925352 · Data updated 2026-11-12
This looks at whether giving newborns their mother's CMV-fighting T cells together with the antiviral drug valganciclovir helps babies born with moderate-to-severe congenital CMV.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York Medical College NIH-funded |
| Lab location | 1 site (Valhalla, United States) |
| Project start | September 1, 2023 |
| Project end | May 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $324,998 |
| NIH project number | 5R01FD007837-02 |
| Project ID | NIH-10925352 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are newborns diagnosed with moderate-to-severe congenital CMV acquired in utero whose mothers can provide CMV-specific immune cells and who meet safety criteria for cell therapy and antiviral treatment.
✕Less likely to help
Babies with mild or asymptomatic congenital CMV, those too old for neonatal intervention, or infants with medical contraindications to cell therapy or valganciclovir may not be expected to benefit from this trial.
What this research studies
If your baby has moderate-to-severe congenital CMV acquired before birth, this trial would randomly assign them to receive either standard antiviral medicine (valganciclovir) alone or valganciclovir plus CMV-specific T cells taken from the mother. The treatment uses the mother's own CMV-targeting CD4 and CD8 T cells to boost the baby's ability to fight the virus while the antiviral drug works. The team has experience making and giving viral cytotoxic T lymphocytes and will monitor viral levels, immune responses, and developmental outcomes over time. Participation involves specialized cell collection, infusion, and close follow-up at the treating center.
Why it matters
Potential benefit: If successful, this approach could help clear CMV infection faster and lower the risk of long-term hearing, developmental problems, and death in affected newborns.
How similar studies have gone: Virus-specific T-cell therapies have shown benefit for CMV in transplant and immunocompromised patients, but using mother-derived CMV T cells in newborns is novel and less tested.
Where this research is happening
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New York Medical College
Valhalla, United States Active
Researchers
- Principal investigator: Cairo, Mitchell S. — New York Medical College
- Study coordinator: Cairo, Mitchell S.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.