NCT03634683

A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lion TCR Pte. Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	LioCyx	Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2018-08-16
• Last updated: 2022-06-30

Locations

3 sites across 2 countries: China, Singapore