Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Infections

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis

Hepatitis B

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Herpes Simiae (B Virus)

Hematinics

All Drugs and Chemicals

Liver Extracts

This is a single-arm study.

Patients will receive escalating doses of LioCyx on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycle. A 21-day treatment break will be given between each cycle.

Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR

LioCyx

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.

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

Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs

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.

Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients

Compare the quality of life of patients based on \[Functional Assessment of Chronic Illness Therapy- Hepatobiliary (FACIT-Hep), version 4\]

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation	NCT03634683	Recurrent Hepat...	LioCyx	21 Years -	Lion TCR Pte. Ltd.
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation	NCT03634683	Recurrent Hepat...	LioCyx	21 Years -	Lion TCR Pte. Ltd.

Spots Global Cancer Trial Database for post liver transplantation