NCT03899415Unknown1 期
TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety evaluation based in Incidences of adverse events/serious adverse events
研究概览
简要总结
This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expression of the specific human leukocyte antigen (HLA) class I profile
- •Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
- •BCLC stage C
- •At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
- •Laboratory criteria:
- •Liver function: Child A, ALT < 200 U/L, AST < 200 U/L, Tbil < 17.1umol/L
- •Renal Function: Creatinine clearance ≥ 60ml/minute
- •Cardiac Function: No abnormality in cardiac enzyme and ECG
- •Pulmonary Function (Lung): No abnormality in chest X-ray
- •Sexually active subjects must be willing to use an acceptable method of contraception
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
排除标准
- •Subject experiencing acute infection or gastric bleeding within 30 days
- •Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
- •Known history of testing positive for human immunodeficiency virus (HIV)
- •Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
- •Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
- •Women who are pregnant or breast-feeding
- •History of allergic reaction to blood products or investigational products
- •History of chronic alcoholism or drug abuse/addiction
- •Require systemic medications, such as steroids during the period of study drug administration
- •Exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy 6 months prior to study drug administration
- •Use of any investigational product (IP) or investigational medical device
- •Any condition which could jeopardize the safety of the patient and his/her compliance in the study
研究组 & 干预措施
TCR-Redirected T Cells
Experimental
HBV antigen specific TCR redirected T cells
干预措施: TCR redirected T cells (Biological)
结局指标
主要结局
Safety evaluation based in Incidences of adverse events/serious adverse events
时间窗: Up to 1 month after the last infusion
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
次要结局
- Overall survival rate(Up to 5 years from the last infusion)
- Overall Response Rate(Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first))
研究者
研究点 (1)
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