Safety and Efficacy of IPM001 in Patients With Advanced Hepatocellular Carcinoma

Inclusion Criteria:

1. Subjects who understand and voluntarily sign the informed consent forms;
2. Subjects aged 18-75 years old (inclusive), male or female;
3. Subjects with progressive hepatocellular carcinoma who failed second-line therapy;
4. Subjects with an expected survival ≥ 6 months;
5. Subjects with a Child-Pugh score ≤ 7;
6. Subjects with an HLA A-02 genotype;
7. Subjects with a TBS score < 8;
8. Subjects with an ECOG score of 0-2 (inclusive);
9. Male and female subjects of childbearing potential must agree to use highly effectivecontraceptive methods during the entire study and for at least 3 months afterreceiving the last treatment, and women of childbearing age must have a negativepregnancy test;
10. Weight: Male > 50 kg, female > 45 kg;
11. Subjects with liver tumor lesions that can be used for tumor tissue biopsy. Iffeasible, the subjects must agree to provide tumor tissue specimens at baseline;
12. Subjects with no major organ dysfunctions (by laboratory test): ① white blood cellcount ≥ 3.0 × 109/L; ② neutrophil count ≥ 1.5 × 109/L; ③ hemoglobin ≥ 90 g/L; ④platelet count ≥ 30 × 109/L; ⑤ total bilirubin ≤ 2 × ULN; ⑥ Serum AST (GOT) and ALT (GPT) ≤ 2.5 × ULN; ⑦ albumin ≥ 3.0 g/dL (30 g/L); ⑧ blood creatinine ≤ 1.5 × ULN; ⑨generally normal bleeding and coagulation time, with PT prolongation ≤ 4 s; ⑩ noserious cardiopulmonary diseases;
13. For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) orhepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with thefollowing conditions are eligible to be enrolled:
14. HBV-HCC: resolved HBV infection (specified as with positive HBV surface antibodyand HBV core antibody, negative HBV surface antigen, and the HBV-DNA below thelower limit of detection); chronic HBV infection (specified as with positive HBVsurface antigen or the HBV-DNA above the lower limit of detection, as well as theHBV-DNA less than 106 copies/mL), with concomitant antiviral therapy.
15. HCV-HCC: resolved or active HCV infection (specified as with positive HCVantibody or the HCV-RNA above the lower limit of detection, as well as theHCV-RNA less than 103 copies/mL), where concomitant antiviral therapy may begiven for active HCV infection.
16. Subjects with no obvious genetic diseases;
17. Subjects who have not received any live attenuated vaccines within 4 weeks prior tothe first administration;
18. Subjects who are able to follow the clinical study protocol and follow-up procedures.

Exclusion Criteria:

1. Subjects with immunodeficiency or a history of autoimmune disorders (e.g., rheumatoidarthropathy, systemic lupus erythematosus, vasculitis, multiple sclerosis,insulin-dependent diabetes mellitus, etc.);
2. Subjects with severe concurrent medical diseases, including severe heart disease,cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension,serious infection and infectious disease, active peptic ulcer, presence of activehemorrhage, and severe organ failure;
3. Subjects with myocardial infarction, severe or unstable angina, coronary or peripheralartery bypass grafting, Grade III or IV cardiac failure defined by the New York HeartAssociation (NYHA), epileptic seizure, and mechanical or paralytic ileus within 6months prior to the first administration of the investigational drug;
4. Subjects who have received chemotherapy and hormonal therapy within 28 days prior tosigning the informed consent forms, or are currently taking other investigationaldrugs;
5. Subjects with lymphoma, leukemia, myelodysplastic syndrome (MDS), or myelosuppression;
6. Subjects with allergy or a history of hypersensitivity to human blood albumin, or ahistory of allergy or hypersensitivity to any investigational drug or its excipients;
7. Subjects with chronic diseases requiring immunotherapy or hormonal therapy; andsubjects currently receiving corticosteroids for other diseases (except those usingtopical or inhaled steroids);
8. Pregnant or lactating women;
9. Subjects with mental or neurological disorders that are not easily controlled;
10. Subjects infected with human immunodeficiency virus (commonly known as AIDS) ortreponema pallidum (commonly known as syphilis);
11. Subjects with a history of other malignant tumors within the last 5 years;
12. Subjects with prior allogeneic stem cell transplantation or solid organ transplant;
13. Subjects with a history of drug or alcohol abuse;
14. Subjects with any irAE of ≥ Grade 3 following prior immunotherapy;
15. Subjects who, in the judgment of the investigator, are not suitable to participate inthis clinical study (e.g., with poor compliance).