Phase 2 Study Testing Addition of N-803 to Chemoimmunotherapy for Children and Young Adults With Relapsed or Refractory Neuroblastoma

What this Trial Is About

This research focuses on children and young adults with relapsed or refractory neuroblastoma, a type of cancer that has not fully responded to previous treatment or has returned after treatment. The study aims to assess the feasibility, tolerability, and response of adding N-803, a novel IL-15 super-agonist, to a chemoimmunotherapy regimen including irinotecan, temozolomide, hu14.18K322A, and GM-CSF. It is a phase 2 randomized trial with an initial safety assessment run-in phase. Participants in the safety run-in phase receive cycles of irinotecan, temozolomide, hu14.18K322A, GM-CSF, and N-803. If the treatment is found tolerable, the phase 2 study proceeds with patients randomized to either chemoimmunotherapy alone or chemoimmunotherapy plus N-803. Patients progressing on chemoimmunotherapy alone may switch to the combination treatment. Pharmacokinetic and biological studies are conducted throughout the trial. During the trial, participants undergo up to 10 cycles of treatment, each lasting 21 days. Researchers monitor treatment feasibility, response rates, toxicity profiles, progression-free survival, and overall survival. Safety and disease progression are closely tracked, with assessments continuing for up to 36 months after enrollment or randomization. The study is sponsored by St. Jude Childrens Research Hospital and is designed to gather comprehensive data on this combination therapy for neuroblastoma.

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