Back to resultsA Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
Primary Purpose
Recurrent Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LioCyx
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Hepatocellular Carcinoma focused on measuring recurrent hepatocellular carcinoma, hepatitis B virus-related, post liver transplantation, HCC
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
Sites / Locations
- The Third Affiliated Hospital of Sun Yat-Sen University
- The First Affiliated Hospital of Sun Yat-Sen University
- National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LioCyx
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Overall Survival according to mRECIST
Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients
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]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03634683
Brief Title
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Major changes in manufacturing process and investigational product
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lion TCR Pte. Ltd.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Hepatocellular Carcinoma
Keywords
recurrent hepatocellular carcinoma, hepatitis B virus-related, post liver transplantation, HCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LioCyx
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
LioCyx
Intervention Description
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Primary Outcome Measure Information:
Title
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Description
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
Time Frame
Start of Treatment until 28 days post last dose
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
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)
Title
Overall Survival according to mRECIST
Description
Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients
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)
Title
Quality of life of patients
Description
Compare the quality of life of patients based on [Functional Assessment of Chronic Illness Therapy- Hepatobiliary (FACIT-Hep), version 4]
Time Frame
Baseline to 28 days post treatment (end of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
We'll reach out to this number within 24 hrs