NCT02723942撤回1 期
Chimeric Antigen Receptor-Modified T Cell (CAR-T) Immunotherapy for Hepatocellular Carcinoma (HCC) Targeting Glypican-3 (GPC3)
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Radiological assessment
研究概览
简要总结
The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma.
详细描述
Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor targeting glypican-3(GPC3) antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safety and efficacy of CAR-T cell immunotherapy in treating with GPC3 positive malignant glioma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-70 years.
- •Gender:both.
- •GPC3 high expression hepatocellular carcinoma patients.
- •Non diffuse hepatocellular carcinoma，no extrahepatic metastasis or portal vein vascular invasion.
- •Degree of liver cirrhosis：class A or class B 7 according to Child-puge grading standard.
- •Routine blood test：white blood cell count（WBC)>=3×10^9/L, Lymphocyte percentage>=15%, hemoglobinHbo（Hb）>=90g/L, prothrombin time（PT） prolongation<=50% normal value, Cluster of differentiation 3(CD3) positive T cell count>=0.8×10^9/L.
- •Liver and Pancreatic function：Alanine aminotransferase/Aspartate transaminase(ALT/AST)<=5 times of the normal value, total bilirubin(TBiL)<=3.0mg/dL, albumin(ALB)>=35g/L, prothrombin time(PT):International Normalized Ratio(INR)<=1.7 or prothrombin time(PT) prolongation<=4s, Serum lipase<=1.5 times of the normal value, Serum amylase<=1.5 times of the normal value.
- •Renal function：Serum creatinine(SCr)<=221μmol/L(2.5mg/L).
- •Karnofsky Performance Status(KPS)>=60；Expected survival time>=12 weeks.
- •Peripheral venous access ；no contraindication of lymphocyte separation.
- •No other serious complications.
- •Voluntarily signed informed consent.
排除标准
- •Pregnant and lactating women.
- •Lymphocyte separation or peripheral venous access cannot be performed in patients .
- •Patients in the active stage of infection or with coagulation disorders.
- •Patients with a previous history of hepatic coma.
- •Patients with severe gastrointestinal ulcers or gastrointestinal bleeding.
- •Patients with organ transplantation or waiting for organ transplantation.
- •Patients with anticoagulant therapy.
- •Patients with antiplatelet therapy.
- •Serum sodium(Na)<125 mmol/L.
- •Serum potassium(K)<3.5 mmol/L(except patients up to the standards after the use of supplements).
- •Patients with organ failure：
- •cardiac function：level three or above according to New York Heart Association (NYHA) criteria.
- •liver function:class C or above according to Child-puge grading standard.
- •renal function:Chronic kidney disease(CKD) phase 4 or more; renal insufficiency phase Ⅲ or more.
- •pulmonary function：severe respiratory failure symptoms, involving other organs.
- •Brain function:central nervous system abnormalities or disturbance of consciousness.
- •Patients with non controlled infectious diseases,for example,HIV positive, syphilis, hepatitis A, hepatitis B, hepatitis C, hepatitis E virus (HEV) positive etc.
- •Patients used corticosteroids or other immunosuppressive agents in the past 4 weeks.
- •Patients with autoimmune disease.
- •Patients with previous history of gene therapy.
- •The actual transfection rate of T cells was lower than 30% or the proliferation was less than 5 times after costimulation.
- •Patients participated in other drug trials in the past 4 weeks.
- •Patients received radiation treatment in the past 4 weeks.
- •Patients do not meet the criteria above.
结局指标
主要结局
Radiological assessment
时间窗: 3 months
Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
次要结局
- The safety of CAR-T cell immunotherapy (adverse events)(4 weeks)
- Peripheral blood tumor markers(3 months)
- CAR-T cell testing(3 months)
研究者
研究点 (1)
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