NCT06196294招募中1 期
GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid 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: 2024年5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 third generation of GPC3/mesothelin targeted CAR-γδT cells 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-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.
详细描述
- Choose appropriate patients with advanced solid cancers, with written consent for this study;
- Perform biopsy to determine the expression of GPC3 or Mesothelin of the tumors by western blotting or IHC;
- Collect blood from the patients and isolate mononuclear cells, select and grow γδT cells and transfect the γδT cells with GPC3 or Mesothelin targeting CAR, amplify the transfected γδT cells as needed, test the quality and killing activity of the CAR-γδT 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
- 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 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 GPC3 or 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 GPC3/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 γδT 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 γδT cell persistence(Six years)
研究者
研究点 (1)
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