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
研究组 & 干预措施
SCG101 + PD1/PD-L1 checkpoint inhibitor
SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
干预措施: PD1/PD-L1 checkpoint inhibitor (Biological)
SCG101 + PD1/PD-L1 checkpoint inhibitor
SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
干预措施: SCG101 (Genetic)
SCG101
SCG101 will be given via Intravenous (IV) infusion.
干预措施: SCG101 (Genetic)
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)