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

  • End date
    Nov 17, 2027
  • participants needed
  • sponsor
    Y-mAbs Therapeutics
Updated on 7 October 2022
monoclonal antibodies
bone marrow procedure
colony stimulating factor
high-risk neuroblastoma


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


Each patient will receive treatment for up to 101 weeks following the first Naxitamab administration. After the end of trial visit, each patient will enter a long-term follow-up where they will be monitored for up to 5 years after first treatment cycle.

Each investigational cycle is started with 5 days, days -4 to 0, of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5, totalling 9 mg/kg per cycle.

Treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial response followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. End of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.

Condition Neuroblastoma
Treatment GM-CSF + hu3F8, GM-CSF + Naxitamab
Clinical Study IdentifierNCT03363373
SponsorY-mAbs Therapeutics
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
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
Life expectancy ≥ 6 months

Exclusion Criteria

Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
Evaluable neuroblastoma outside bone and bone marrow
Existing major organ dysfunction > Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
Active life-threatening infection
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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