Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
研究概览
简要总结
The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer
详细描述
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients' age from 18 years to 70 years.
- •Patients who have a life expectancy of at least 3 months.
- •pathologically confirmed non-small cell lung cancer.
- •failed in previous standard chemotherapy and targeted therapy.
- •Karnofsky performance status 0-
- •adequate organ functions.
排除标准
- •Pregnant and lactating women.
- •Patients with T cell lymphoma, syphilis, AIDS or combination
- •Patients with highly allergic or have a history of severe allergies
- •Patients with severe hepatic or renal dysfunction
- •Patients with severe autoimmune disease or who is being treated with immunosuppressive agents
- •Patients with severe infection not controlled or High fever
- •Patients with organ transplantation or waiting for organ transplantation.
- •Patients with brain metastasis
- •Patients with severe coagulopathy (e.g. hemophilia)
- •Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.
研究组 & 干预措施
HEKT cell
Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
干预措施: HEKT cell (Biological)
结局指标
主要结局
safety：safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment
时间窗: 2 years
Occurrence of study related adverse events as assessed by CTCAE v4.0
次要结局
- efficacy: complete response; partial response; stable disease; progression disease; progression free survival.(2 years)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital