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CTB001 is a fourth-generation autologous chimeric antigen receptor (CAR) T-cell therapy targeting Claudin 18.2 (CLDN18.2), a tight junction protein that is highly expressed in various solid tumors but has restricted expression in normal tissues. Developed by Bioheng Biotech using their proprietary Bioheng Explored CAR-T platform, CTB001 is designed to enhance anti-tumor efficacy and safety in the treatment of solid malignancies. While Bioheng Biotech is primarily recognized for its allogeneic "off-the-shelf" universal CAR-T pipeline, CTB001 was developed as an autologous product to provide clinical validation for the company's technology. The therapy has received Orphan Drug Designation from the U.S. FDA for gastric cancer and has demonstrated promising results in exploratory clinical studies for multiple indications, including pancreatic cancer and lung adenocarcinoma.
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