Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Proportion of patients who have objective response in the tumor
研究概览
简要总结
This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.
详细描述
Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count >1000/mm3. Spironolactone will be started orally on day -1, given three times daily till cessation of GM-CSF.
Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapsed or refractory neuroblastoma
- •Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU/L, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air
- •Karnofsky or Lansky performance status score ≥50
- •Has an appropriate HLA-haploidentical NK-cell donor available
排除标准
- •Pregnant or lactating woman
- •HIV infection
- •Patients for whom conventional treatment is deemed more appropriate
- •Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy <1 month
研究组 & 干预措施
Intervention
Quadruple immunotherapy
干预措施: Natural killer cell (Biological)
Intervention
Quadruple immunotherapy
干预措施: Dinutuximab beta (Drug)
Intervention
Quadruple immunotherapy
干预措施: Interleukin-2 (Drug)
Intervention
Quadruple immunotherapy
干预措施: Granulocyte-Macrophage Colony-Stimulating Factor (Drug)
Intervention
Quadruple immunotherapy
干预措施: Spironolactone (Drug)
Intervention
Quadruple immunotherapy
干预措施: Naxitamab (Drug)
结局指标
主要结局
Proportion of patients who have objective response in the tumor
时间窗: 1-2 months
Objective response = complete response + partial response + minor response + stable disease
次要结局
- Overall survival at 1 year(up to 1 year)
- Percentage of donor NK cells(up to 1 year)
- Progression-free survival(up to 1 year)
- Proportion of patients who have tumor relapse(up to 1 year)
- Number of patients who experience adverse events(up to 1 month)
研究者
Cheuk Ka Leung Daniel
Consultant
Hong Kong Children's Hospital