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

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.

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