A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

February 1, 2028

Study Completion Date

February 1, 2029

Conditions
Neuroblastoma Recurrent
Interventions
DRUG

Temozolomide

IV, Days 1-5

DRUG

Irinotecan

IV, Days 1-5

DRUG

hu14.18K322A

IV over 4 hours daily times 4 doses, Days 2-5.

DRUG

N803

Subcutaneous (SC), Day 6.

DRUG

Sargramostim

Subcutaneous injection (preferred) or IV, Days 7-13.

Trial Locations (1)

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER