A Phase I Study of T Cell Receptor-Redirected T Cell Infusion For Prevention of Hepatocellular Carcinoma Recurrence in Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To Evaluate safety of the TCR-T treatment
研究概览
简要总结
Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population.
详细描述
A open-label, cohort clinical study of T cell receptor-redirected T cells to prevent recurrence of HBV-related hepatocellular carcinoma after liver transplantation. Subjects will be enrolled into the observation cohort or treatment cohort.
Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing autologous T cells after confirming eligibility. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse.
Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T) treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as hepatocellular carcinoma (HCC)
- •Underwent liver transplantation
- •Seropositive for hepatitis B surface antigen (HBsAg), or presence of HBV DNA or HBV RNA before liver transplantation
- •Expression of TCR-T target epitopes within specific human leukocyte antigen (HLA) class I profile
- •No major post-operative complication
- •Life expectancy of at least 3 months
- •Ability to provide informed consent
- •Ability to comply with study procedures
排除标准
- •Known, clinically suspected or has history or central nervous system (CNS) and bone metastasis
- •Significant ongoing immunologic rejection based on pathology and clinical diagnosis
- •Evidence or history of significant bleeding diathesis or coagulopathy
- •Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
- •Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •Women who are pregnant or breast-feeding
- •Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
结局指标
主要结局
To Evaluate safety of the TCR-T treatment
时间窗: Start of Treatment until 28 days post last dose
Measures include - assessments of Adverse Events (AEs) and Serious AEs,
次要结局
- To evaluate Progression Free Survival rate(Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first))
- To evaluate Duration of response rate(Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first))
- To evaluate objective response rate(Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first))