CMV CTLs in Neonates With CMV Infection

Recruiting now · Phase 2

Conditions studied: Congenital Cytomegaloviral (CMV) Disease

In brief

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

Key facts

Study ID

NCT05564598

Run by

New York Medical College

People needed

23

Starts

2023-07-01

Expected to finish

2028-10-31

Last updated by the study team

2026-03-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• New York Medical College — Valhalla, New York, United States (enrolling)
• Nationwide Children's Hosptial — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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