GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma

Inclusion Criteria: 18-75 years-old, male or female Voluntarily willing to participate in the study and sign the written informed consent form Life expectation ≥12 weeks Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1 Histologically-confirmed hepatocellular carcinoma (HCC) No benefits from curative surgery or other local therapies are expected at screening, judged by investigators Radiologically-confirmed progression disease after at least one prior line of systematic treatment and limited benefits from current guideline or consensus for hepatocellular carcinoma are expected at screening, judged by investigators Fresh samples or FFPE, immunohistochemistry (IHC)-stained GPC-3 positive with intensity ++ or +++ Per RECIST v1.1, at least one measurable lesion Manageable lung metastasis Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7 No active HBV infections Adequate organ functions Adequate venous access for APH Non-hematological AEs induced by previous treatment must have recovered to CTCAE ≤1, except for alopecia and peripheral neuropathy Women of childbearing potential must agree to use an effective and reliable contraceptive method during 28 days prior to lymphodepletion to 1 year post infusion; Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive method since lymphodepletion to 1year post infusion, and sperm donation is prohibited during the study Women of childbearing potential must have negative serum β-hCG test result at screening and 48 hours prior to lymphodepletion Exclusion Criteria: Cholangiocarcinoma or histological-mixed hepatocellular cholangiocarcinoma Active brain metastasis Primary lesion or infused lesions with the longest diameter ≥15cm, or other potential risk which might not be appropriate for further study treatment judged by the investigator Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors) Systematic autoimmune disorders requiring long-term systematic immunosuppression Previously treated with any genetically engineered modified T cell therapy (TCR-T/CAR-T) or other CGT Active HCV, HIV, or syphilis History of organ transplant Uncontrolled or active infection at screening, prior to APH, 72 hours prior to lymphodepletion or 5 days prior to JWATM214 infusion With severe cardiovascular disease History or presence of clinically-relevant CNS disorders Current presence of hepatic encephalopathy ≥G2 hemorrhage within 30 days prior to screening, or in need of long-term anticoagulants Active digestive ulcer or gastrointestinal bleeding within 3 months prior to screening Pregnant or lactating women Not satisfying wash-out period for APH Unable or unwilling to comply with the study protocol, judged by the investigator Other situations implying that the subject might not be appropriate to participate in the study Previously allergic or intolerable to JWATM214 or its components