NCT01212341已完成1 期
A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine the MTD of allogenetic NK cells
研究概览
简要总结
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Histologically or cytologically confirmed malignant lymphoma or solid tumor
- •After the failure of standard treatment
- •KPS >70 or ECOG PS 0-2
- •Adequate bone marrow, renal, and liver functions
- •Expected survival at least 3 months
- •Informed consent
排除标准
- •Pregnancy or lactating woman
- •HIV patients
- •Prior exposure to cell-based therapy
- •Hypersensitivity to interleukin-2
- •Patients with autoimmune disease
研究组 & 干预措施
Singe-dose infusion
Experimental
Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg
干预措施: Allogeneic NK cells (Biological)
Repeated dose infusion
Experimental
Cohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg
干预措施: Allogeneic NK cells (Biological)
结局指标
主要结局
To determine the MTD of allogenetic NK cells
时间窗: 4-5 weeks
DLT is defined as follows: * Any toxicity at grade 3 or over for 5 days or more * All grade 4 toxicities * GVHD at grade 2 or over
次要结局
- To evaluate the safety(4 -5 weeks)
- To evaluate the pharmacokinetics of allogeneic NK cells(4-5 weeks)
- To determine the overall response rate(4-5 weeks)
研究者
研究点 (1)
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