The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of adverse events
研究概览
简要总结
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.
详细描述
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≧18years, gender unlimited.
- •Failure or intolerance after at least first-line treatment.
- •GPC3 positive(IHC)
- •Patients must have at least one target lesion available for evaluation.
- •BCLC B or C.
- •Child-Pugh grade A or B
- •ECOG is 0 or 1 (one week before enrollment.)
- •Estimated life expectancy ≥ 3 months.
- •Functioning of major organs are normal.
- •Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
- •Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
排除标准
- •There are uncontrollable active infections that need systemic treatment.
- •HIV antibody is positive or syphilis antibody is positive.
- •Pregnant or lactating women.
- •hepatic encephalopathy.
- •patients with organ failure:
- •Heart: NYHA heart function grade IV;
- •Liver: Grade C that achieves Child-Turcotte liver function grading;
- •Kidney: kidney failure and uremia;
- •Lung: symptoms of respiratory failure;
- •Brain: a person with a disability.
- •It is undergoing systemic hormones therapy.
- •Impact results show that over 50% of the liver is occupied by tumor .
- •Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection.
- •Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion.
- •Abnormal thyroid function ≧Level
- •Active autoimmune diseases require systemic treatment during the first two years of screening.
- •Patients have mental illness or history of drug abuse.
- •Patients are participating in other clinical studies.
- •The researchers found that it was unsuitable for the recipients to be enrolled.
结局指标
主要结局
Percentage of adverse events
时间窗: 12months
Percentage of participants with adverse events.
次要结局
- Objective Remission Rate(ORR)(12months)
- Proliferation ratio of CAR-T cells(12months)