A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)

Exclusion Criteria

• •1\. History of a second primary malignancy is permitted, unless the patient has undergone potentially curative treatment and has been free of the disease for 5 years.
• •Note: This time requirement (i.e., within 5 years) does not apply to patients with adequately treated carcinoma in situ of the cervix, localized squamous cell carcinoma of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma \<T1. Patients with prostate cancer under active surveillance are also eligible, or patients deemed eligible by the investigator after thorough evaluation.
• •2\. Prior treatment with CAR-T or TCR-T cell therapy targeting any antigen or therapeutic cancer vaccines; or prior treatment with any therapy targeting GPC3.
• •3\. Prior to apheresis, the patient has received the following antitumor therapies: Cytotoxic therapy within 14 days; Small molecule targeted therapy, epigenetic therapy, or experimental drug therapy within 14 days or at least 5 half-lives (whichever is longer), or treatment with invasive experimental medical devices; Monoclonal antibody therapy within 21 days; Immunomodulatory therapy within 7 days; Radiotherapy within 14 days.
• •4\. Toxicities from prior antitumor therapies have not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0), except for alopecia, Grade 2 peripheral neuropathy, and hypothyroidism controlled by hormone replacement therapy.
• •5\. History of organ transplantation or currently awaiting organ transplantation (including liver transplantation).
• •6\. Brain metastases with central nervous system symptoms or other clinically significant central nervous system diseases.
• •7\. History of hepatic encephalopathy or current presence of hepatic encephalopathy.
• •8\. Ascites requiring therapeutic intervention (excluding any ascites detected by imaging that does not require clinical intervention).
• •9\. HCC tumor volume occupying ≥50% of the normal liver volume based on imaging, or presence of tumor thrombus in the main portal vein or inferior vena cava, or patients deemed ineligible by the investigator.
• •10.Women who are pregnant or breastfeeding.
• •11.Positive screening for hepatitis C virus antibody (HCV-Ab) or human immunodeficiency virus antibody (HIV-Ab); active syphilis. (Patients with positive HCV antibody but HCV-RNA below the detection limit of the research center are allowed to enroll).
• •12.Presence of severe underlying diseases, such as: Evidence of severe active viral, bacterial, or uncontrolled systemic fungal infections; Active or unstable autoimmune diseases or a history of autoimmune diseases within the past 3 years with potential for recurrence (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators is excluded); Uncontrolled diabetes; Severe congestive heart failure classified as New York Heart Association (NYHA) Class III or above, or patients with an ejection fraction \<50%; history of myocardial infarction or unstable angina within 6 months prior to treatment; Hypertension that cannot be controlled to the following range (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg) despite treatment with two antihypertensive medications; Clinically significant ventricular arrhythmias, or a history of unexplained syncope not due to vasovagal causes or dehydration; patients with constrictive pericarditis, significant pericardial effusion, cardiomyopathy, low voltage on limb leads of electrocardiogram, or other cardiac conditions deemed unsuitable by the investigator; Patients with clinically significant dementia, altered mental status, or a history of poorly controlled psychiatric disorders.
• •13.History of stroke or seizure within 6 months prior to signing the ICF.
• •14.Significant bleeding tendency, such as active gastrointestinal bleeding or coagulation disorders.
• •15.Chronic diseases requiring systemic corticosteroids or other immunosuppressive therapy, or treatment with systemic corticosteroids (≥70 mg prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 7 days prior to apheresis, except for the following: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic purposes (e.g., prevention of contrast agent allergy).
• •16.Administration of live attenuated vaccines within 4 weeks prior to apheresis.
• •17.Major surgery within 2 weeks prior to apheresis, or planned surgery during the study period (Note: Study participants scheduled for local anesthesia surgery may participate in this study).
• •18.History of severe allergic reactions, or hypersensitivity to any drugs or related excipients specified in the protocol, as determined by the investigator to be unsuitable for enrollment.
• •19.Any condition that, in the opinion of the investigator, makes the study participant unsuitable for participation in this study.