Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC

Inclusion Criteria:

1. Confirmed pathologic or radiologic diagnosis of HCC ;
2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the locallaboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if noarchived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
3. Unresectable stage B (intermediate) or C (advanced) HCC according to the BarcelonaClinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not beeligible for, surgical or locoregional therapy;
4. Received at least two prior line of systemic therapy (included but not limited totarget therapy, immunotherapy or chemotherapy) with radiologic disease progressionduring or following systemic therapy;
5. Child-Pugh A or B7, no history of hepatic encephalopathy;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICFsignature;
7. Estimated life expectancy of minimum of 12 weeks;
8. Must have at least 1 target lesion

Exclusion Criteria:

1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cordcompression;
2. Prior bone marrow or organ transplantation;
3. Have a history of another primary malignancy within 5 years prior to starting studytreatment. Exceptions here are as follows: the disease under study; adequately treatedbasal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
4. Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis Bcore antibody [HBcAb] positive, then HBV-DNA must be < 20 IU/mL, and HBsAg-positivepatients should have been treated with antiviral therapies as per the localguidelines);
5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody,Cytomegalovirus(CMV) DNA or syphilis serology;
6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy,CAR-T therapy;
7. Inadequate bone marrow reserve or organ function;
8. History or current evidence of any condition or disease that could confound theresults of the study or, in the opinion of Investigator, is not in the best interestof the patient to participate.
9. Pregnant or Breast-feeding women.