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 2 Recruiting 10 enrolled Shaare Zedek Medical Center Y-mAbs Therapeutics · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2026-06-23
Primary completion: 2028-06
Completion: 2032-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naxitamab	Monoclonal antibody	—	—
Background	GM-CSF	Protein / enzyme biologic	—	—

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

Summary

Timeline

Drugs

Indications