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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China
National University Hospital
Singapore, Singapore
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
Time frame: Start of Treatment until 28 days post last dose
Overall Response Rate
Tumor assessment will be according to mRECIST. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST from baseline.
Time frame: 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)
Overall Survival according to mRECIST
Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients
Time frame: 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)
Quality of life of patients
Compare the quality of life of patients based on \[Functional Assessment of Chronic Illness Therapy- Hepatobiliary (FACIT-Hep), version 4\]
Time frame: Baseline to 28 days post treatment (end of treatment)
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