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This is an autologous chimeric antigen receptor (CAR) T-cell therapy targeting Claudin18.2 (CLDN18.2), a tight junction protein frequently overexpressed in gastrointestinal malignancies such as gastric and pancreatic cancers. Developed by Shenzhen University General Hospital in collaboration with Shenzhen Haoshi Biotechnology, the therapy involves genetically modifying a patient's own T cells to express a CAR specific for CLDN18.2 along with a truncated EGFR (tEGFR) marker, which can serve as a selection tool or a safety switch. The therapy is currently being evaluated in a Phase 1 clinical trial (NCT05620732) for patients with advanced pancreatic and gastric cancers who have failed standard treatments. Early clinical results have demonstrated significant efficacy, including complete and partial remissions, although on-target off-tumor toxicities such as gastric mucosal injury have been observed due to the expression of CLDN18.2 in normal gastric tissues.
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