An Exploratory Clinical Study on the Safety and Efficacy of Autologous Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CG-102-12C) in the Treament of Advanced Hepatocellular Carcinoma
This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.
• 1\. The study participant has fully understood the potential risks and benefits of participating in this study and has signed the informed consent form.
• 2\. Aged 18-75 years (inclusive of 18 and 75 years old).
• 3\. Patients with advanced hepatocellular carcinoma (HCC) confirmed by histopathological or cytological examination to be GPC3-positive (advanced HCC is defined as Barcelona Clinic Liver Cancer (BCLC) stage C or stage B that is unsuitable for or has progressed after local treatment, including ablation therapy, interventional therapy, and radiotherapy). Patients must have previously received systemic standard treatment and experienced treatment failure or intolerance (systemic treatments include, but are not limited to, chemotherapy and molecular targeted therapy). Treatment failure is defined as disease progression during or after the most recent treatment.
• 4\. Immunohistochemical analysis of tumor tissue samples must show GPC3 positivity (defined as \>25% of pathological specimens with IHC-detected GPC3-positive cells and staining intensity ≥1+). Preferably ,target lesion specimens will be used, including freshly obtained tumor pathology samples or archived tumor pathology samples deemed acceptable by the investigator.
• 5\. Child-Pugh score ≤7.
• 6\. At least one evaluable tumor lesion as assessed by RECIST 1.1.
• 7\. ECOG performance status score of 0-2.
• 8\. Expected survival ≥3 months.
• 9\. Hematological parameters must meet the following criteria:Absolute neutrophil count (ANC) ≥1×10\^9/L;Absolute lymphocyte count (ALC) ≥0.5×10\^9/L;Platelets ≥50×10\^9/L;Hemoglobin ≥60 g/L or hematocrit \>0.24.(No treatment with hematopoietic growth factors or blood transfusion within 3 days prior to laboratory tests).
• 10.Blood biochemistry must meet the following criteria:Total bilirubin (TBIL) ≤2.5 times the upper limit of normal (ULN);AST and ALT ≤5.0 times ULN;Serum albumin ≥28 g/L;Serum creatinine ≤1.5 times ULN;Creatinine clearance \>50 mL/min (calculated using the Cockcroft-Gault formula).
• 11.Coagulation parameters must meet the following criteria:INR \<1.5 times ULN;APTT \<1.5 times ULN;PT prolongation ≤4 seconds.
• 12.If the patient is HBsAg positive or HBcAb positive, it is required that HBV-DNA ≤2000 IU/mL;
• 13.At screening, during apheresis, and within 3 days prior to preconditioning, female study participants of childbearing potential must have a negative blood pregnancy test; during the study period and for at least 1 year after completion of the study treatment, study participants of childbearing potential and their partners must use effective contraception.