A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
研究概览
简要总结
Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with a natural high-avidity TCR directed towards the HLA-A*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.
详细描述
This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically or cytologically confirmed, or imaging diagnosed HCC
- •HLA-A *02 genotyping
- •HBsAg positive in serum or tumor tissue
- •Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
- •Child-Pugh score ≤ 7
- •ECOG performance status of 0 or 1
- •Life expectancy of 3 months or greater
- •Patient with adequate organ function
排除标准
- •Uncontrolled portal vein or inferior vena cava tumor thrombosis
- •Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases
- •Active or uncontrollable infections
- •History of organ transplantation
- •Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample
- •History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- •Prior exposure to any cell therapy
- •Other severe medical conditions that may limit subject's participation in this trial
结局指标
主要结局
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
时间窗: 28 days
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
次要结局
- Efficacy: antiviral activity of SCG101(Up to 2 years)
- Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC(Up to 2 years)