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

June 27, 2022 updated by: Lion TCR Pte. Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangzhou, China, 510000
        • The Third Affiliated Hospital of Sun Yat-sen University
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: LioCyx
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Time Frame: Start of Treatment until 28 days post last dose
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
Start of Treatment until 28 days post last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
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)
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)
Overall Survival according to mRECIST
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)
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)
Quality of life of patients
Time Frame: Baseline to 28 days post treatment (end of treatment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lion TCR Pte. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTCR-HCC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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