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

Conditions

• Neuroblastoma Recurrent

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Temozolomide — DRUG
  IV, Days 1-5
• Irinotecan — DRUG
  IV, Days 1-5
• hu14.18K322A — DRUG
  IV over 4 hours daily times 4 doses, Days 2-5.
• N803 — DRUG
  Subcutaneous (SC), Day 6.
• Sargramostim — DRUG
  Subcutaneous injection (preferred) or IV, Days 7-13.

Study Details

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

Key Dates

Start date

Nov 10, 2025

Status verified

Jun 2026

Primary completion

Feb 1, 2028

Completion

Feb 1, 2029

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Chemoimmunotherapy
  Patients will be randomized to receive chemoimmunotherapy alone.
• Experimental: Chemoimmunotherapy + N-803
  Patients will be randomized to receive chemoimmunotherapy plus N-803.
• Experimental: Safety Run-In Treatment Schedule - Chemoimmunotherapy + N-803
  The first 6 patients included in the safety assessment run-in phase will receive cycles of irinotecan, temozolomide, hu14.18K322A, GM-CSF and N-803. If fewer than 2 patients in the first cohort of 6 patients experience a DLT in Cycle 1, then the trial will proceed to Phase 2. If 2 or more of the first 6 patients experience a DLT in Cycle 1 then the N-803 will be dose reduced to 15 mcg/kg and 6 more patients will be enrolled in the safety assessment run-in. Once the safety assessment run-in phase is completed, patients will be enrolled onto the phase 2 study.

Primary Outcome Measure

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 [ Time Frame: Complete Cycle 1 treatment (each cycle is 21 days) ]

Central Contacts

• Sara Federico, MD
  888-226-4343
  [email protected]

Locations (4)

Find similar trials in San Francisco, CA

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