NCT04842812招募中1 期
Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors
Second Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of TILs/CAR-TILs treatment in advanced solid cancers
研究概览
简要总结
Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.
详细描述
- Choose appropriate patients with advanced lung or other cancers, with written consent for this study;
- Perform biopsy or collect cancerous effusion in thorax or abdomen to obtain TILs by standard protocol;
- Grow TILs and engineered the tumor-effective TILs with CRISPRA-CAS9 technique to knockdown PD1 and electronic-transfection strategy to express scFvs that target PD1 and CTLA4; amplify the engineered T cells as needed, test the quality and killing activity of the TILs and then transfuse them back the patients via systemic or local injections via standard protocol, and follow up closely to collect related parameters as needed;
- To enhance the killing capability, tumor-noneffective TILs have also been genetically engineered to express various CARs targeting HER2/Mesothelin/Lewis-Y/PSCA/MUC1/ GPC3/AXL/EGFR/Claudin18.2/B7-H3/ROR1/GD2/AXL/Claudin6-DAP10 with knockdown of PD1/HPK1 as appropriate;
- Evaluate the clinical results as needed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced cancers that failed to current available therapies;
- •Life expectancy >12 weeks;
- •Adequate heart, lung, liver, kidney functions;
- •Available for tumor biopsy or cancerous effusions;
- •Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
排除标准
- •Had accepted gene therapy before;
- •Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity;
- •Active infectious disease related to bacteria, virus, fungi, et al;
- •Other severe diseases that the investigators consider not appropriate;
- •Pregnant or lactating women;
- •Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
- •Other conditions that the investigators consider not appropriate.
结局指标
主要结局
Safety of TILs/CAR-TILs treatment in advanced solid cancers
时间窗: up to 36 months
Assessing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
次要结局
- Primary clinical efficacy of the TILs/CAR-TILs treatment in advanced solid cancers(15 years)
研究者
研究点 (1)
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