CMV CTLs in Neonates With CMV Infection

PHASE2RecruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2028

Conditions
Congenital Cytomegaloviral (CMV) Disease
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"

Trial Locations (4)

10595

RECRUITING

New York Medical College, Vallhala

43205

RECRUITING

Nationwide Children's Hosptial, Columbus

63130

RECRUITING

Washington University, St Louis

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

Sponsors
All Listed Sponsors
lead

New York Medical College

OTHER

NCT05564598 - CMV CTLs in Neonates With CMV Infection | Biotech Hunter | Biotech Hunter