Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells

• Registration Number: NCT06961617
• Lead Sponsor: Lion TCR Pte. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LioCyx-M	LioCyx-M, HBV antigen-specific TCR-redirected T cells	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Up to 2 years	To evaluate the anti-tumor efficacy of LioCyx-M
Overall Survival (OS)	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

Trial Locations

Locations (1)

Gaobo Boren Hospital; 🇨🇳 Beijing, China