A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma

Inclusion Criteria:

1. 18-75 years-old, male or female
2. Voluntarily willing to participate in the study and sign the written informed consentform
3. Life expectation ≥12 weeks
4. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
5. Histologically-confirmed hepatocellular carcinoma (HCC)
6. No benefits from curative surgery or other local therapies are expected at screening,judged by investigators
7. Radiologically-confirmed progression disease after at least one prior line ofsystematic treatment and limited benefits from current available options forhepatocellular carcinoma are expected at screening, judged by investigators
8. Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained GPC-3 positive
9. Per RECIST v1.1, at least one measurable lesion
10. Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
11. No active infections of hepatitis B virus
12. Adequate organ functions
13. Adequate venous access for apheresis
14. Non-hematological AEs induced by previous treatment must have recovered to CTCAE ≤1,except for alopecia and peripheral neuropathy
15. Women of childbearing potential must agree to use an effective and reliablecontraceptive 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 ofchildbearing potential must agree to the use of a barrier contraceptive method sincelymphodepletion to 1year post infusion, and sperm donation is prohibited during thestudy
16. Women of childbearing potential must have negative serum β-human chorionicgonadotropin (β-hCG) test result at screening and 48 hours prior to lymphodepletion

Exclusion Criteria:

1. Active brain metastasis
2. Primary lesion or infused lesions with the longest diameter ≥15 cm, or other potentialrisk which might not be appropriate for further study treatment judged by theinvestigator
3. Another primary malignancy within 3 years (with some exceptions forcompletely-resected early-stage tumors)
4. Systematic autoimmune disorders requiring long-term systematic immunosuppression
5. Previously treated with any genetically engineered modified T-cell therapy nor othercell-gene therapy
6. Active infections of hepatitis C virus (HCV), human immunodeficiency virus (HIV), orsyphilis
7. Uncontrolled or active infection at screening, prior to apheresis, 72 hours prior tolymphodepletion or 5 days prior to JWATM204 infusion
8. With severe cardiovascular disease History or presence of clinically-relevant centralnervous system (CNS) disorders
9. With clinically-significant CNS disorders
10. Current presence of or previously with hepatic encephalopathy
11. ≥G2 hemorrhage within 30 days prior to screening, or in need of long-termanticoagulants
12. Pregnant or lactating women
13. Not satisfying pre-defined wash-out period for apheresis
14. Received plasma exchange within 14 days prior to apheresis
15. Unable or unwilling to comply with the study protocol, judged by the investigator, orother situations implying that the subject might not be appropriate to participate inthe study
16. Vaccinated with live vaccinations against infectious diseases within 8 weeks prior toJWATM204 infusion
17. Previously allergic or intolerable to JWATM204 or its components