Clinical trial · Interventional
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
NCT06961617CI-TRIAL-00089449recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LioCyx-M, HBV antigen-specific TCR-redirected T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LioCyx-M
- description
- LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10\^6 cells/kg body weight (BW).
- interventionNames
- Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells
Primary outcomes (2)
- measure
- Assessments of adverse events/serious adverse events
- timeFrame
- Start of treatment until 28 days post last dose
- description
- To evaluate the safety of LioCyx-M
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 2 years
- description
- To evaluate the anti-tumor efficacy of LioCyx-M
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * HCC diagnosis confirmed by histology/ cytology or clinically * HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies * Has failed at least one line of systemic therapy for HCC * ECOG performance status ≤1 * Serum HBsAg positivity * Child-Pugh A (5 - 7 points) * Life expectancy of at least 1 year * HLA profile: HLA-A\*02:01 or HLA-A\*24:02 Exclusion Criteria: * Brain metastasis * Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors * Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy. * Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration * Serum HBV DNA levels ≥ 200 IU/ml at screening * Serum HBsAg levels ≥ 10,000 IU/ml at screening * Women who are pregnant or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.