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RECRUITING
NCT05564598
PHASE2

CMV CTLs in Neonates With CMV Infection

Sponsor: New York Medical College

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

DRUG

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