A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow



Children (≥ 1 year), adolescents and young adults with high-risk neuroblastoma can participate in this clinical study. The aim is to study the efficacy and safety of the combination therapy of naxitamab (also known as hu3F8) and GM-CSF (granolocyte-macrophage-colony-stimulating factor). Patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who had only a partial or minor response to previous therapy or who had stable disease may be included in this clinical study.

 Naxitamab is given via infusions on days 1, 3, and 5 of each treatment cycle (28 days). 

Main inclusion criteria

  • Age ≥ 1 year
  • High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.


Y-mAbs Therapeutics

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