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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2027
  • participants needed
    95
  • sponsor
    Y-mAbs Therapeutics
Updated on 23 March 2022
monoclonal antibodies
bone marrow procedure
colony stimulating factor
high-risk neuroblastoma
hu3f8

Summary

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

Description

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.

Details
Condition Neuroblastoma
Treatment GM-CSF + hu3F8, GM-CSF + Naxitamab
Clinical Study IdentifierNCT03363373
SponsorY-mAbs Therapeutics
Last Modified on23 March 2022

Eligibility

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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