Clinical Study of GPC3-targeted Chimeric Antigen Receptor T Cells fo Treating Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patient with dose limiting toxicity
研究概览
简要总结
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.
Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.
The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.
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 positive HCC, tumor size >= 5 cm, cannot receive standard treatment, Expected survival time>=3 months.
- •Routine blood test: white blood cell count（WBC)>= 2.5×10^9/L, hemoglobin (Hb)>= 9.0 g/dL, blood platelet >= 60×10^9/L, Lymphocyte percentage>=15%.
- •Blood biochemical parameters: ALB >= 30 g/L, ALT <= 5 times of the normal value, AST <= 5 times of the normal value, serum lipase<=1.5 times of the normal value, serum amylase<=1.5 times of the normal value， total bilirubin <= 2.5 times of the normal value.
- •Prothrombin time INR < 1.
- •Ejection fraction (EF) >= 55%, oxygen saturation (SO2) > 90%.
- •No allergic reaction to contrast material.
- •Karnofsky score >= 60%.
- •Child-puge score <
- •Peripheral venous access.
- •Voluntarily signed informed consent.
排除标准
- •Pregnancy or lactation.
- •Systemic steroid treatment ( >prednisone equivalent/kg/day).
- •Patients with previous history of cell immunotherapy or antibody therapy.
- •Patients received radiotherapy/chemotherapy in the past 4 weeks.
- •Patients are participating in other clinical trials.
- •Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
- •Patients with acute allergic reaction.
- •History of liver transplantation.
- •Patients with anticoagulant treatment.
- •Patients with hepatic encephalopathy.
- •Eligible for hepatectomy, liver transplantation or other standard treatment.
- •Unstable gastrointestinal and respiratory bleeding.
- •Active viral, fungal or bacterial infections.
- •Heart failure classification (NYHA): II-IV.
- •Patients are unable or unwilling to comply with the requirements of the study protocol.
- •Patients do not meet the criteria above.
结局指标
主要结局
Number of patient with dose limiting toxicity
时间窗: 2 months
After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.
次要结局
- Radiological evaluation of tumor size after CAR- T immunotherapy(3 months)
- Peripheral tumor marker(3 months)
- Number of Peripheral CAR-T cell(3 months)
研究者
Beicheng Sun
Director of Hepatobiliary Surgery
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School