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

NCT ID: NCT03634683

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2022-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LioCyx

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.

Group Type: EXPERIMENTAL

LioCyx

Intervention Type: BIOLOGICAL

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

Interventions

LioCyx

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lion TCR Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China; Singapore

Other Identifiers

LTCR-HCC-001

Identifier Type: -

Identifier Source: org_study_id