Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
研究概览
简要总结
To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
详细描述
HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age < 21 years old
- •Patients with high-risk solid tumors who failed prior HDCT/autoSCT
- •Patients with a suitable haploidentical donor
- •High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
- •stable disease with salvage chemotherapy after relapse
排除标准
- •organ dysfunction(NCI common toxicity criteria grade > 2)
- •progression of disease despite salvage chemotherapy
结局指标
主要结局
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
时间窗: within 30 days after transplantation
次要结局
- event-free survival and overall survival(3 years after transplantation)
研究者
KiWoong Sung
Professor
Samsung Medical Center