Mother's immune cells could help fight severe CMV in newborns
NCT ID NCT05564598
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding special immune cells from the mother to standard antiviral medicine can safely and more effectively treat moderate to severe CMV infection in newborns. Babies up to 21 days old with confirmed CMV disease may join. All receive antiviral drugs, and some also get the mother's CMV-fighting cells. The goal is to see if the combination clears the virus better and is safe.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 21 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: ≤ 21 days of life * Birth Weight: ≥ 2500 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital Los Angeles
RECRUITINGLos Angeles, California, 90027, United States
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Nationwide Children's Hosptial
RECRUITINGColumbus, Ohio, 43205, United States
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New York Medical College
RECRUITINGValhalla, New York, 10595, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63130, United States