Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options
• Serum HBsAg positivity
• Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
• Life expectancy of at least 3 months
• HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A*02:01 or HLA-A*24:02).

Key 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
• Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
• Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.
• Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
• 7. Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells
• Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
• Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
• Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
• Serum HBV DNA levels ≥ 200 IU/ml at screening
• Serum HBsAg levels ≥ 10,000 IU/ml at screening
• Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
• Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation
• Women who are pregnant or breast-feeding