NCT06995872View on ClinicalTrials.gov

Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

October 28, 2025

Primary Completion Date

June 1, 2028

Study Completion Date

June 1, 2029

Conditions
Neuroblastoma
Interventions
DRUG

rhIL-15

rhIL-15 will be given at a dose of 0.13-2 mcg/kg/day (based on dose level) as a continuous IV infusion for 5 days each cycle.

DRUG

Dinituximab

Dinituximab will be given at a dose of 17.5 mg/m\^2/dose by IV on days 2-5 of each cycle.

DRUG

Temozolomide

Temozolomide will be given orally (PO) at a dose based on weight on days 1-5 of each cycle beginning with cycle 2.

DRUG

Irinotecan Hydrochloride

Irinotecan will be given at a dose of 50 mg/m\^2/dose by IV on days 1-5 of each cycle beginning with cycle 2.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT06995872 - Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma | Biotech Hunter | Biotech Hunter