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
Sponsor study identifier
Secondary identifiers
interventional
23
1 country
4
Study Start
July 1, 2023
Actual (reported)Primary Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. There is a cross-over design for patient assigned to SOC only if they have persistent disease. Funding source: FDA OOPD
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2022
Actual (reported)October 3, 2022
Actual (reported)July 1, 2023
Actual (reported)October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To determine the safety of giving CMV CTLs combined with anti-viral therapy in neonates with CMV
the incidence and severity of Grade I-IV acute GVHD within 8 weeks that is probably or directly related to CMV-CTL infusion after last CMV CTL infusion will be evaluated to determine the safety profile of CMV CTLs in neonates
12 weeks
To determine response rates to treatment with CMV CTLS and anti-viral medication
response rates will be measured by monitoring CMV PCR levels. A complete response to CMV-CTLs will be those with undetectable viral load by qRT-PCR
12 weeks
The first 3 patients enrolled will receive both anti-viral medication and CMV CTLs, and treatment will be staggered every 28 days from the last dose of CMV CTLs from the prior patient.
Patients will receive both anti-viral medication and CMV CTLs
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.
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Washington University
St Louis, Missouri, 63130, United States
Mitchell Cairo, MD
New York Medical College
First Submitted
September 26, 2022
First Posted
October 3, 2022
Study Start
July 1, 2023
Actual (reported)Primary Completion
October 31, 2027
EstimatedPatients will only receive anti-viral therapy
Patients assigned to the SOC may be eligible to cross-over to the CVM CTL treatment if they are not responding to SOC treatment with continued elevated CMV levels.
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
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New York Medical College
Vallhala, New York, 10595, United States
Nationwide Children's Hosptial
Columbus, Ohio, 43205, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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