CMV CTLs in Neonates With CMV Infection

• Status: Not yet recruiting
• Trial end date: 2026-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Treatments: Antiviral Agents; Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

1. Age: ≤ 21 days of life 2. Birth Weight: ≥ 2500 gms 3, Gestational age: ≥ 34 weeks of age

4. Diagnosis of CMV viremia, viruria, and/or infection

Either one or more:

4.1 Elevated CMV by RT-PCR in urine, saliva, CSF, or plasma; and/or 4.2 Positive urine culture for CMV

5. 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

6. Minimal Organ Criteria

6.1 Hematological ANC ≥ 750/mm3 HgB ≥ 8gm/dl Platelets ≥ 20,000/kmm3 6.2 Renal Serum creatinine ≤ 1.0 mg/dl 6.3 Hepatic ALT/SGOT ≤3x upper normal limits

7 Donor Availability 7.1 Maternal haploidentical donor. 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 -

1. 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.

2. Concomitant enrollment in another experimental clinical trial investigating the treatment of neonatal CMV viremia and/or infection.

3. Any medical condition that could compromise participation in the study according to the investigator's assessment.

4. Known history of HIV infection in the mother.

5. Patient's legally authorized representative unwilling or unable to comply with the protocol or unable to give informed consent.