CMV CTLs in Neonates With CMV Infection
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
New York Medical College
23 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
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. Funding source: FDA OOPD
Eligibility
Inclusion Criteria25
- 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 Criteria5
- 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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Interventions
Patients will receive maternal CMV CTLs on day 0. Additional doses of CMV CTLs may be re-infused at a minimum of every two weeks for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg) only in patients not achieving a CR and no prior dose limiting toxicity of any prior dose.
All patients will receive anti-viral therapy with one of the following: 4.2.2 Valganciclovir Dosing: 16 mg/kg/dose PO q12h OR 4.2.3 Ganciclovir Dosing: 6 mg/kg/dose IV q12h Dose adjustments: * Reduce dose by 50% for ANC less than 500 cells/mm3 * Hold the dose if ≤ 200 cells/mm3 until recovery ≥ 500 cells/mm3 * Treatment will continue for 6 months
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05564598