Treatment for newborns with congenital CMV infection using immune cells
Official title: A Phase II Open-Label Randomized Study of Anti-Viral Antibiotic Therapy With and Without Familial (Maternal) Cytomegalovirus (CMV) Cytotoxic T Lymphocytes (CTLs) in Neonates With Moderate/Severe Maternal Acquired CMV Infection
Run by New York Medical College · NCT05564598 · Data updated 2026-11-12
This study is testing if adding immune cells to standard antiviral treatment can help newborns with congenital CMV infection get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 0 Days to 21 Days |
| Sex | All |
| Enrollment | 23 (estimated) |
| Sponsor | New York Medical College Academic / other |
| Drugs / interventions | prednisone |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2028 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT05564598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates under 21 days old with moderate to severe congenital CMV disease and a maternal donor who meets specific criteria.
✕Probably not a fit
Patients who do not have a maternal donor with a CMV response or who do not meet the inclusion criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of cytotoxic T-lymphocytes (CTLs) in treating neonates with moderate to severe congenital cytomegalovirus (CMV) disease. Eligible patients, who are less than 21 days old and have a maternal donor with a CMV response, will receive antiviral therapy alongside CTL treatment. The study consists of a safety run-in phase followed by a randomized phase to compare the effectiveness of antiviral therapy alone versus antiviral therapy combined with CTLs. The goal is to enhance the immune response against CMV and improve patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and lasting defense against complications from congenital CMV infection in neonates.
How similar studies have gone: While the use of CTLs in treating viral infections is a promising approach, this specific application in neonates with congenital CMV is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≤ 21 days of life * Birth Weight: ≥ 2500 gms. . For babies with intrauterine growth retardation (IUGR) (small for gestational age \[SGA\]) \> 1500 gms * Gestational age: ≥ 34 weeks of age * Diagnosis of CMV viremia, viruria, and/or infection:Either one or more: Elevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and/or Positive urine culture for CMV \- Moderate or Severe CMV Disease Any one or more of the following attributable to congenital CMV infection: * Thrombocytopenia (≤ 50,000 mm3) * Multiple petechiae * Hepatomegaly * Splenomegaly * Intrauterine growth retardation * Increased transaminases * Increased bilirubin * Microcephaly * Ventriculomegaly * Intracerebral calcifications * Periventricular echogenicity * Cortical or cerebral malformation * Chorioretinitis * Severe neonatal hearing loss * CMV DNA by PCR in CNS * Increased WBC for age in CNS * Minimal Organ Criteria Hematological: ANC ≥ 750/mm3, HgB ≥ 8gm/dl, Platelets ≥ 20,000/kmm3 Renal: Serum creatinine ≤ 1.0 mg/dl Hepatic: ALT/SGOT ≤3x upper normal limits * Donor Availability: Maternal donor available with a T-cell response CMV MACS® PepTivators. the donor is considered suitable if the percentage of IFN-gamma+ T cells is \> 0.01% after stimulation with PepTivators. Exclusion Criteria - * Patient receiving steroids (\> 0.5 mg/kg prednisone equivalent) on the same day of CMV CTL infusion. Antenatal steroids for lung maturation will have been cleared prior to CMV diagnosis. * Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection. * Any medical condition that could compromise participation in the study according to the investigator's assessment. * Known history of HIV infection in the mother. * Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.
Where it's running
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Children's Hospital Los Angeles
Los Angeles, California, United States Recruiting -
Washington University
St Louis, Missouri, United States Recruiting -
New York Medical College
Vallhala, New York, United States Recruiting -
Nationwide Children's Hosptial
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Mitchell Cairo, MD — New York Medical College
- Study coordinator: Mitchell Cairo, MD
- Email: mitchell_cairo@nymc.edu
- Phone: 914-594-2150
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.