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SCG101 is an investigational autologous, hepatitis B virus (HBV)-specific T-cell receptor (TCR) engineered cell therapy developed by SCG Cell Therapy. It consists of a patient’s own (autologous) T cells that are genetically modified via lentiviral transduction to express a high-affinity, high-avidity natural TCR specific for an epitope of the hepatitis B surface antigen (HBsAg), presented on infected hepatocytes and hepatocellular carcinoma (HCC) cells. Upon administration, these engineered cells recognize and bind to HBsAg-positive cells—both those infected with HBV and those transformed into cancer—leading to cytotoxic elimination through both cytolytic and non-cytolytic mechanisms. Preclinical and clinical studies have demonstrated significant antiviral activity, tumor inhibition, reduction in serum HBsAg levels, eradication of covalently closed circular DNA (cccDNA), and favorable safety in patients with advanced HBV-related HCC who had failed prior therapies. The product leverages proprietary technology from SCG Cell Therapy for identifying optimal virus-specific TCRs.
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