A Phase I/II, Open Label, Single Arm, Multicenter Study of LioCyx in Subjects With Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
研究概览
简要总结
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients.
While there are limited treatment measures for HBV-related HCC recurrences, the study hypothesized that LioCyx is capable of lysing target liver cells expressing the HBV cognate antigens and provide clinical benefit to patients with HBV-related HCC.
详细描述
The study is a Phase I/II, open label, single-arm, multicenter study of LioCyx. Subjects with recurrent hepatitis B virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled.
Approximately 6-12 subjects will be enrolled in Phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of LioCyx"
All subjects will be followed up for survival until death.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation
- •Life expectancy of 3 months or greater
- •Have measurable disease by the revised response evaluation criteria in solid tumors (mRECIST)
- •History of positive test for hepatitis B virus surface antigen (HBsAg)
- •Expression of LioCyxTM target epitopes within specific human leukocyte antigen (HLA) class I profile
- •Had received treatment with at least one standard therapy or refused, appropriate approved therapy for their disease
- •21 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Willing and able to comply with all study procedures
排除标准
- •Known, clinically suspected or has history of central nervous system (CNS) and bone metastasis
- •Tumor burden in the liver exceeding 70%
- •Significant ongoing immunologic rejection based on pathology and clinical diagnosis
- •Evidence or history of significant bleeding diathesis or coagulopathy
- •Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
- •Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- •Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
- •Women who are pregnant or breast-feeding
结局指标
主要结局
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
时间窗: Start of Treatment until 28 days post last dose
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
次要结局
- Overall Response Rate(Start of Treatment until first documented CR or PR, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first))
- Quality of life of patients(Baseline to 28 days post treatment (end of treatment))
- Overall Survival according to mRECIST(Start of Treatment until first protocol-defined PD, and survival follow up until death, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first))