确诊高风险神经母细胞瘤、原发难治性疾病或抢救治疗后骨及／或骨髓反应不完全的儿童及成人患者，将接受 naxitamab 及粒细胞-巨噬细胞集落刺激因子（GM-CSF）治疗最多 101 周。患者将于首次给药后随访最多五年。 Naxitamab，又称 hu3F8，是一种靶向 GD2 的人源化单克隆抗体。
适应症：Neuroblastoma
入组条件
纳入标准
- 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
排除标准
- 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
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。