Major changes in manufacturing process and investigational product

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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