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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06961617

Enrollment

Registered

2025-05-08

Start date

2024-06-01

Completion date

2028-12-01

Last updated

2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

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.

Interventions

DRUGLioCyx-M, HBV antigen-specific TCR-redirected T cells

Via intravenous (IV) infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessments of adverse events/serious adverse events	Start of treatment until 28 days post last dose	To evaluate the safety of LioCyx-M
Objective Response Rate (ORR)	Up to 2 years	To evaluate the anti-tumor efficacy of LioCyx-M

Secondary

Measure	Time frame	Description
Overall Survival (OS)	Up to 2 years	To evaluate the anti-tumor efficacy of LioCyx-M
Duration of Response (DoR)	Up to 2 years	To evaluate the anti-tumor efficacy of LioCyx-M
Progression Free Survival (PFS)	Up to 2 years	To evaluate the anti-tumor efficacy of LioCyx-M

Countries

China

Contacts

Primary ContactWang Zhe

zhe.wang@liontcr.com+86 15902091916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026