- Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow — Active Not Recruiting • Phase II • NCT03363373.
- Naxitamab (anti-GD2 antibody) plus GM-CSF treats high-risk neuroblastoma resistant to initial or salvage chemotherapy, with five-year follow-up.
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Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2 Conditions: Neuroblastoma Interventions: GM-CSF + Naxitamab Lead Sponsor: Y-mAbs Therapeutics Planned Enrollment: 122 participants