A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
研究概览
简要总结
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
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
- •Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- •Subjects with HCC who have received standard systemic therapies
- •HLA-A *02
- •BCLC stage B or C
- •Child-pugh score ≤ 7 ol
- •Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
- •Have at least one measurable leasion at baseline as per mRECIST and iRECIST
- •Life expectancy of 3 months or greater
- •The organ function is in good condition.
排除标准
- •Subjects with history of another primary cancer within 5 years
- •Central nervous system metastasis and clinically significant central nervous system disease
- •Previous or current coexistence of hepatic encephalopathy
- •Currently present with symptomatic third space fluid accumulation
- •Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
- •Known history of neurological or mental disorder, including epilepsy or dementia
- •Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
- •Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
- •Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
- •Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
研究组 & 干预措施
SCG101
干预措施: SCG101 (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
时间窗: Start of SCG101 infusion until disease progression or 12 months post infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
时间窗: Start of SCG101 infusion until disease progression or 12 months post infusion
Per mRECIST and iRECIST
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
时间窗: Start of SCG101 infusion until disease progression, an average of 24 months
Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Persistences of viral vector copy number (VCN) after SCG101 infusion
时间窗: Start of SCG101 infusion until disease progression, an average of 24 months
次要结局
未报告次要终点