NCT04745403招募中1 期
Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment
研究概览
简要总结
This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options
- •Serum HBsAg positivity
- •Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
- •Life expectancy of at least 3 months
- •HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A*02:01 or HLA-A*24:02).
排除标准
- •Brain metastasis
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
- •Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
- •Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.
- •Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
- •Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells
- •Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
- •Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- •Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
- •Serum HBV DNA levels ≥ 200 IU/ml at screening
- •Serum HBsAg levels ≥ 10,000 IU/ml at screening
- •Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
- •Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
mRNA HBV/TCR T-cells
Experimental
Escalating regime from 1x10e5 to 5-10x10e6 cells/kg bodyweight (BW) every 2 weeks.
干预措施: mRNA HBV/TCR T-cells (Drug)
结局指标
主要结局
Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment
时间窗: Start of treatment until end of study
Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines
Safety evaluation of mRNA HBV/TCR T-cell treatment
时间窗: Start of treatment until 28 days post last dose
Based on incidence and severity of adverse events
次要结局
- Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment(Up to 4 years)
研究者
研究点 (1)
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