NCT04951141Unknown早期 1 期
Beijing Immunochina Medical Science & Technology Co., Ltd.
Beijing Immunochina Medical Science & Technology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
研究概览
简要总结
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GPC3 expression was positive by histological examination;
- •18-69 years old;
- •The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor;
- •The patients who received traditional palliative therapy had an expected survival period of more than 4 months;
- •Organ status allows clinical application.a. Creatinine < 1.5mg/dl; b. Cardiac ejection index > 55%; c. Heme > 9g / dl, bilirubin < 2.0mg/dl;
- •No bleeding and coagulation disorders were found;
- •There was no allergy to contrast medium;
- •Contraception: contraceptive measures were taken during clinical application and within 3 months after the last cells transfusion;
- •There is no other contraindication for lymphocyte collection;
- •Sign informed consent.
排除标准
- •Pregnant or lactating women;
- •Patients need systemic steroids therapy;
- •At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment;
- •Patients received radiotherapy within 4 weeks after enrollment;
- •Patients received other cell modification therapy in the early stage;
- •In the screening stage, patients with lymphocyte transfection rate less than 5%, or T cell culture can not expand (< 5 times) patients;
- •Uncontrolled symptoms or other diseases include, but are not limited to, infection, congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or limiting the social environment that meets the requirements, or the researchers believe that they may bring unpredictable risks;
- •Patients with severe acute allergic reactions;
- •Patients who participated in other clinical trials;
- •Researchers believe that patients are not suitable to participate.
结局指标
主要结局
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
时间窗: 2 years
次要结局
- Objective response rate (ORR)(2 years)
- Overall survival (OS)(2 years)
研究者
研究点 (2)
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