Actively Recruiting
CMV CTLs in Neonates With CMV Infection
Led by New York Medical College · Updated on 2026-03-30
23
Participants Needed
4
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CMV CTLs in Neonates With CMV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 days or younger
- Birth weight at least 2500 grams
- Gestational age 34 weeks or more
- Diagnosis of CMV infection confirmed by PCR or urine culture
- Moderate or severe CMV disease with symptoms like thrombocytopenia, petechiae, hepatomegaly, splenomegaly, growth retardation, increased liver enzymes, microcephaly, brain abnormalities, chorioretinitis, severe hearing loss, or CNS involvement
- Blood and organ function criteria: ANC at least 750/mm3, hemoglobin at least 8 gm/dl, platelets at least 20,000/kmm3, serum creatinine 1.0 mg/dl or less, liver enzymes within 3 times upper normal limits
- Availability of maternal donor with specific T-cell CMV response
You will not qualify if you...
- Receiving steroids higher than 0.5 mg/kg prednisone equivalent on the day of CMV CTL infusion
- Participation in another experimental trial for neonatal CMV treatment
- Any medical condition that the investigator feels would prevent study participation
- Known maternal HIV infection
- Legal representative unable or unwilling to follow the study protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
3
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
4
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Mitchell Cairo, MD
CONTACT
E
Edo Schaefer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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