NCT03656705已完成1 期
Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma
Xinxiang medical university1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年9月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled.
- •2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
- •3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.
排除标准
- •1.Pregnancy or breastfeeding.
- •2.Known HIV, HBV or HCV infection.
- •3.Active antoimmune disease.
- •4.History of severe immediate hypersensitivity to any of the biological products including penicillin.
- •5.Severe psychiatric disorder which might interfere with the study treatment or examination.
- •6.Chronic heart failure NYHA≧III.
- •7.Simultaneous participation in another clinical trial within 4 weeks.
结局指标
主要结局
Objective Response Rate
时间窗: up to one year
Non-small cell lung carcinoma to CCCR-NK92 cell infusions
Number of participants with adverse events evaluated with CTCAE,version 4.0
时间窗: 3 months
Safety evaluation
次要结局
- Disease Control Rate(up to one year)
- Progression-free Survival(up to one year)
- Overall Survival(up to one year)
研究者
研究点 (1)
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