NCT07537400

Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5

Phase II Trial of Naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Combination With Induction Chemotherapy for Patients With Newly-Diagnosed High-Risk Neuroblastoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 12 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.

Detailed description

This clinical trial will use the backbone of the St. Jude NB2012 protocol which assessed the hu14.18K322A anti-GD2 antibody with COG type induction. The current study will replace the hu14.18K322A with Naxitamab. Naxitamab is an anti-GD2 antibody that was evaluated as part of multiple chemoimmunotherapy protocols with favorable side effect profile and proven efficacy. Patients will receive COG type recommended therapy as administered on ANBL1531 and NB2012 protocols with the addition of Naxitamab and GM-CSF to Induction Cycles 1-5. Further treatment, including: Consolidation, Radiation and Post-Consolidation therapy will be given at the discretion of the treating physician. Patients will undergo complete assessment prior to trial enrollment, after 2 cycles, and post chemotherapy to allow for accurate assessment of response to treatment. If less than partial response, the patient will be taken off the protocol. A patient diagnosed with progressive disease at any stage of treatment will be taken off the protocol. Follow-up assessments will be carried out post surgery, and every 4 months for 5 years from diagnosis.

Conditions

• High-Risk Neuroblastoma

Interventions

Type	Name	Description
DRUG	Naxitamab	Naxitamab and GM-CSF administered with COG type induction chemotherapy.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-06-01
• Completion: 2032-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study