China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has published the results of the Phase I clinical study for its C-CAR031 at the American Association for Cancer Research (AACR) annual meeting 2023. The open Phase I study was designed to assess the safety and tolerability of C-CAR031, featuring a dose-escalation design that combines accelerated titration with i3+3.
Study Design and Patient Treatment
Patients with advanced hepatocellular carcinoma (HCC), who have been histologically confirmed to be GPC3 antigen positive and have failed systemic treatment after receiving standard clearance treatment, are treated with a single intravenous infusion of C-CAR031. The results showed that C-CAR031 exhibited positive clinical anti-tumor efficacy while exhibiting good safety and tolerability.
Clinical Efficacy and Safety of C-CAR031
According to the RECIST v1.1 and mRECIST standards, in the exploratory dose group (DL2 dose group) of 6 advanced hepatocellular carcinoma patients, 3 patients achieved confirmed partial remission (PR) and 2 patients achieved disease stability. As of the cut-off date, all participants with partial remission (PR) still maintained sustained remission.
C-CAR031: A Second-Generation Autologous CAR-T Cell Therapy
C-CAR031 is a second-generation autologous CAR-T cell that targets the GPC3 antigen. Its product prototype was designed by AstraZeneca, including a safety-optimized antigen recognition scFv (single-stranded variable region) and an armored negative dominant TGF developed based on AstraZeneca’s global innovative cell therapy discovery platform—β Type II receptor.-Fineline Info & Tech
