NCT05779917招募中1 期
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
Second Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月10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
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients with Dose Limiting Toxicity
研究概览
简要总结
The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.
详细描述
- Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study;
- Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC;
- Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;
- To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with advanced cancer that expresses Mesothelin protein;
- •Life expectancy >12 weeks;
- •Adequate heart, lung, liver, kidney, and blood function;
- •Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay;
- •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
Number of Patients with Dose Limiting Toxicity
时间窗: six months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the Mesothelin-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
次要结局
- Percent of Patients with best response as either complete remission or partial remission.(six months)
- Median CAR-T cell persistence(Six years)
研究者
研究点 (1)
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