A Phase 1/ 2a, 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
- 46
- 试验地点
- 4
- 主要终点
- Safety and tolerability of SCG101
研究概览
简要总结
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
详细描述
This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels.
In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.
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 at least 2 standard systemic therapies
- •HLA-A *02
- •BCLC stage B or C
- •Child-pugh score ≤ 7
- •Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
- •Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
- •Life expectancy of 3 months or greater
- •Ability to provide informed consent form
- •Ability to comply with all the study procedures
排除标准
- •Subjects with history of another primary cancer
- •Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
- •Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
- •Known history of neurological or mental disorder, including epilepsy or dementia
- •Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- •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, CAR T/TCR T cell therapy
- •Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- •Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
- •Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
研究组 & 干预措施
SCG101
This is a single arm study.
Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.
干预措施: SCG101 (Biological)
结局指标
主要结局
Safety and tolerability of SCG101
时间窗: Start of SCG101 infusion until 100 days post SCG101 infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Tumor response of SCG101 (Phase 2)
时间窗: Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
次要结局
- Preliminary clinical efficacy of SCG101(Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.)
- Antiviral activity before and after SCG101 infusion(Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.)
- Change in pharmacodynamic markers (PD) before and after SCG101 infusion(Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.)
- Persistence of viral vector copy number (VCN) after SCG101 infusion(Start of SCG101 infusion until disease progression, an average of 24 months.)