NCT06961617招募中1 期
Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
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
- Assessments of adverse events/serious adverse events
研究概览
简要总结
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC diagnosis confirmed by histology/ cytology or clinically
- •HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
- •Has failed at least one line of systemic therapy for HCC
- •ECOG performance status ≤1
- •Serum HBsAg positivity
- •Child-Pugh A (5 - 7 points)
- •Life expectancy of at least 1 year
- •HLA profile: 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
- •Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
- •Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
- •Serum HBV DNA levels ≥ 200 IU/ml at screening
- •Serum HBsAg levels ≥ 10,000 IU/ml at screening
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
LioCyx-M
Experimental
LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10^6 cells/kg body weight (BW).
干预措施: LioCyx-M, HBV antigen-specific TCR-redirected T cells (Drug)
结局指标
主要结局
Assessments of adverse events/serious adverse events
时间窗: Start of treatment until 28 days post last dose
To evaluate the safety of LioCyx-M
Objective Response Rate (ORR)
时间窗: Up to 2 years
To evaluate the anti-tumor efficacy of LioCyx-M
次要结局
- Duration of Response (DoR)(Up to 2 years)
- Progression Free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
研究者
研究点 (1)
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