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

Recurrent Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03634683
• Other study ID #: LTCR-HCC-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 2018
• Est. completion date: August 2022

Study information

• Verified date: June 2022
• Source: Lion TCR Pte. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Recurrence
• Recurrent Hepatocellular Carcinoma

Intervention

Biological:
• LioCyx
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangzhou
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangzhou
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Lion TCR Pte. Ltd.

Countries where clinical trial is conducted

China,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Start of Treatment until 28 days post last dose
Secondary	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.	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)
Secondary	Overall Survival according to mRECIST	Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients	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)
Secondary	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]	Baseline to 28 days post treatment (end of treatment)