Clinical Trial of Autologous GPC3 CAR-T Cells (CBG166) Therapy for Advanced Hepatocellular Carcinoma
A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma.
• Aged 18 to 70 years, male or female;
• Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;
• Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. In case of stage B, the subject must have disease progression following surgery or local treatment, or be unsuitable for surgery or local treatment;
• Subjects have previously received at least one systemic treatment regimen (including but not limited to targeted therapy, immunotherapy or chemotherapy) with disease progression determined by imaging during or after treatment;
• Cirrhosis status Child-Pugh score:≤7;
• Intrahepatic lesions were confirmed by imaging examination (arterial phase enhancement) within 28 days before the start of treatment. According to the RECIST1.1, there was at least one target lesion that could be stably evaluated;
• Expected survival time \> 12 weeks;
• Expression of GPC3 demonstrated by immunohistochemistry (IHC)
• ECOG Performance Status score: 0 to 1 point;
• Subjects should have adequate organ function;
• Subjects should be HBsAg negative. Subjects with positive HBsAg or positive HBcAb are required to have HBV-DNA \<2000 IU/ml;
• The blood pregnancy test of female subjects of childbearing age should be negative within 7 days before cell therapy and not during lactation; Female or male subjects of childbearing age need to take efficient tools or drug contraceptive measures during the whole research process or within one year after CAR-T cell transfusion (What happens later shall prevail);