A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Main Inclusion Criteria:

* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received at least 2 standard systemic therapies
* HLA-A \*02
* BCLC stage B or C
* Child-pugh score ≤ 7
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
* Life expectancy of 3 months or greater
* Ability to provide informed consent form
* Ability to comply with all the study procedures

Main Exclusion Criteria:

* Subjects with history of another primary cancer
* Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
* Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
* Known history of neurological or mental disorder, including epilepsy or dementia
* Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation