Phase 1 Study of SCG101 T-Cell Therapy for Treatment of Hepatitis B Virus-Related Liver Cancer

What this Trial Is About

Researchers are evaluating SCG101, a TCR-T cell therapy, for patients with Hepatitis B Virus-Related Hepatocellular Carcinoma HBV-HCC. This Phase I clinical trial aims to assess the safety, tolerability, and preliminary effectiveness of SCG101 in treating this form of liver cancer. The study focuses on patients who have already received standard systemic therapies and meet specific disease and health criteria. Participants will receive SCG101 as an infusion of HBsAg-specific TCR autologous T cells at assigned dose levels. The study monitors the incidence of dose-limiting toxicities and adverse events such as cytokine release syndrome and neurotoxicity from the start of infusion until disease progression or up to 12 months. Additional assessments include the therapys clinical efficacy, pharmacodynamic marker changes, and viral vector copy number persistence over an average of 24 months. During the trial, participants will undergo continuous safety and efficacy evaluations, including measuring tumor response using mRECIST and iRECIST criteria. Researchers will monitor organ function and viral markers closely. The total observation period extends until disease progression or for 12 to 24 months post-infusion, allowing comprehensive assessment of treatment effects and long-term safety.

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related