Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent/guardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche) Exclusion Criteria: 1. Significant organ toxicity 2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components. 3. Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding 4. 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 5. Patient is either eligible and able to participate in or is currently participating in an active interventional Y-mAbs sponsored clinical trial wit