Clinical trial · Interventional
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Major changes in manufacturing process and investigational product
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LioCyx | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LioCyx
- 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.
- interventionNames
- Biological: LioCyx
Primary outcomes (1)
- measure
- Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
- timeFrame
- Start of Treatment until 28 days post last dose
- description
- Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
Secondary outcomes (3)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available