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Clinical Trial Active — Not Recruiting Phase II NCT03363373

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

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 •…

📅 15 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT03363373
Start
2018-04-03
Completion
2026-06
ClinicaliQ Trial Snapshot
  • 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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What This Trial Is Studying

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

Full Trial Details
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Eligibility criteria, protocol, and results when available
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