Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 10, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Neuroblastoma, Recurrent, RefractoryNeuroblastoma (NB)Neuroblastoma in Children
Interventions
BIOLOGICAL

Allogenic NK cells infusion

Natural Killer (NK) cells are extracted from a healthy donor through apheresis and processed in a clean room using the CLINIMACS device. After quality assessment, these cells are stored at -198°C until needed. When required, the cells are thawed, washed, and evaluated for viability and sterility before being administered to the patient at a dosage of 5 × 10\^6 cells per kilogram of body weight. Two further injections may be considered based on the patient's response and confirmed improvement via MRI MIBG. Injections are scheduled seven to ten days after each chemotherapy course according to the standard treatment protocol.

Trial Locations (1)

1445613131

RECRUITING

Rasoul Akram Hospital, Tehran

All Listed Sponsors
collaborator

Royan Institute

OTHER_GOV

collaborator

Iran University of Medical Sciences

OTHER

lead

Marzieh Ebrahimi

INDUSTRY