This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).
Confirmed pathologic or radiologic diagnosis of HCC ;
Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
Prior bone marrow or organ transplantation;
Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody [HBcAb] positive, then HBV-DNA must be < 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);