Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorSun Yat-Sen University Cancer Center

About this trial

This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in the treatment of pediatric high-risk and refractory/relapsed neuroblastoma in Sun Yat-sen University Cancer Center.

Eligibility criteria

Qualifiers

None

Disqualifiers

Significant organ toxicity

Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.

Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding

Patient will undergo treatment with another investigational drug, whilst being treated with naxitamab or has received another investigational drug within the 4 weeks prior to commencing treatment with naxitamab

Trial design

Treatments tested in this trial

  • Naxitamab monotherapy
  • GM-CSF
  • Irinotecan
  • Temozolomide
  • Naxitamab in combination therapy
  • GM-CSF with combination regimen
  • Sintilimab

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sun Yat-Sen University Cancer Center

Lead sponsor

Hainan General Hospital

Collaborator