RecruitingPhase 2NCT07085338

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

A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

Sponsor

St. Jude Children's Research Hospital

Enrollment

54 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma Recurrent

Summary

The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed). Primary Aims * To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable * To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF Secondary Aims * To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF * To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803

Eligibility

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new immune-boosting drug called N-803 to a standard combination treatment (immunotherapy plus chemotherapy) can improve outcomes for children and young adults with neuroblastoma — a cancer that typically starts in the nerve tissue near the adrenal glands — that has returned or is not responding to treatment. **You may be eligible if...** - You are under 30 years old - You were originally diagnosed with neuroblastoma (confirmed by biopsy or bone marrow test with elevated urine/blood markers) - Your neuroblastoma is classified as high-risk, and it has returned, is progressing, or has not responded to prior treatment **You may NOT be eligible if...** - You have serious organ dysfunction affecting the heart, liver, kidneys, or lungs - You have active uncontrolled infections - Your overall health is too poor to tolerate treatment - You have not received any prior therapy for neuroblastoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTemozolomide

IV, Days 1-5

DRUGIrinotecan

IV, Days 1-5

DRUGhu14.18K322A

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

DRUGN803

Subcutaneous (SC), Day 6.

DRUGSargramostim

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

Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT07085338

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