A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.
Age >18 years and ≤75 years, male or female.
Histologically confirmed recurrent or metastatic hepatocellular carcinoma (HCC) that is not amenable to surgical resection.
At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Tumor tissue must test positive for GPC3 expression by immunohistochemical (IHC), defined as > 25% of tumor cells staining for GPC3 in the pathological specimen. Preferably, the target lesion sample should be used, including freshly obtained tumor tissue or archival tissue samples deemed acceptable by the investigator.
Pregnant or breastfeeding women, or women of childbearing potential who test positive on a pregnancy test during the screening period).
Active hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection; seropositivity for Human Immunodeficiency (HIV) or syphilis.
Any uncontrolled active infection, including but not limited to active pulmonary tuberculosis.
Therapeutic doses of corticosteroids must be discontinued at least 2 weeks prior to Meta10-GPC3 infusion; any immunosuppressive medications must be discontinued at least 4 weeks before signing the informed consent form.
Zhejiang University
Lead sponsor
Leman Biotech Co., Ltd.
Collaborator