RecruitingPhase 2

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

United States54 participantsStarted 2025-11-10

Plain-language 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

Who can participate

Age range30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment of at least one FDG-PET avid site.
✓. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts)
✓. ANC ≥750/μL, (no short-acting hematopoietic growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors ≤ 14 days of blood draw documenting eligibility); and
✓. Platelet count ≥ 75,000/μL, transfusion independent (no platelet transfusions ≤ 7 days of blood draw documenting eligibility).
✓. Total bilirubin ≤ 1.5 x ULN for age; and,
✓. SGPT (ALT) ≤ 225 U/L (≤ 5x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U/L.
✓. Shortening fraction of ≥ 27% by ECHO, or
✓. Ejection fraction of ≥ 50% by ECHO or gated radionuclide study.

What they're measuring

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

Timeframe: Complete Cycle 1 treatment (each cycle is 21 days)

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

Timeframe: Complete Cycle 1 treatment (each cycle is 21 days)

Timeframe: Up to 10 cycles of irinotecan/temozolomide/hu14.18K322A/GM-CSF with or without N-803 in the Phase 2 (each cycle is 21 days)

Trial details

NCT IDNCT07085338

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Sara Federico, MD

866-278-5833 referralinfo@stjude.org

View on ClinicalTrials.gov More Neuroblastoma Recurrent trials

Plain-language summary

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment of at least one FDG-PET avid site.
✓. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts)
✓. ANC ≥750/μL, (no short-acting hematopoietic growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors ≤ 14 days of blood draw documenting eligibility); and
✓. Platelet count ≥ 75,000/μL, transfusion independent (no platelet transfusions ≤ 7 days of blood draw documenting eligibility).
✓. Total bilirubin ≤ 1.5 x ULN for age; and,
✓. SGPT (ALT) ≤ 225 U/L (≤ 5x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U/L.
✓. Shortening fraction of ≥ 27% by ECHO, or
✓. Ejection fraction of ≥ 50% by ECHO or gated radionuclide study.

What they're measuring

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

Timeframe: Complete Cycle 1 treatment (each cycle is 21 days)

Timeframe: Up to 10 cycles of irinotecan/temozolomide/hu14.18K322A/GM-CSF with or without N-803 in the Phase 2 (each cycle is 21 days)