"Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DNA copy number
研究概览
简要总结
To evaluate the safety and anti-HBV efficacy of γδT cells.
详细描述
In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years old, male or female;
- •Informed consent;
- •Patient who were tested HBsAg and HBeAg positive;
- •HBV DNA loads>1 million copy/ml;
- •Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L;
- •No jaundice, total bilirubin is normal;
- •For patients with new onset, oral antiviral drugs limited for Sebivo.
排除标准
- •Pregnant women;
- •Patients Complicated with other viruses, bacteria infections and other infectious diseases;
- •With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;
- •There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;
- •Other indications that is not suitable for the treatment
结局指标
主要结局
DNA copy number
时间窗: 6 months
Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.
Negative conversion rate of HbeAg
时间窗: 6 months
We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.
次要结局
未报告次要终点
研究者
Zhinan Yin, Ph.D.
Principal Investigator
Jinan University Guangzhou