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CMV CTLs in Neonates With CMV Infection
Sponsor: New York Medical College
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
Official title: 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
Key Details
Gender
All
Age Range
0 Days - 21 Days
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2023-07-01
Completion Date
2028-10-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
CMV Cytotoxic T-Lymphocytes
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.
Anti-viral Therapy
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)
Children's Hospital Los Angeles
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
New York Medical College
Valhalla, New York, United States
Nationwide Children's Hosptial
Columbus, Ohio, United States