NCT03634683

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

July 20, 2018

Last Update Submit

June 27, 2022

Conditions

Recurrent Hepatocellular Carcinoma

Keywords

recurrent hepatocellular carcinomahepatitis B virus-relatedpost liver transplantationHCC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall Response Rate

    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

    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

    Baseline to 28 days post treatment (end of treatment)

Study Arms (1)

LioCyx

EXPERIMENTAL

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

Interventions

LioCyxBIOLOGICAL

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

LioCyx

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Willing and able to comply with all study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510000, China

Location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510080, China

Location

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 16, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

CN(2)SG(1)