NCT05564598RECRUITINGPhase 2Patients 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
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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.