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Claudin 18.2-targeted U-CART is a preclinical-stage universal chimeric antigen receptor T-cell (CAR-T) therapy developed by Fundamenta Biotech Limited (also known as Fundamenta Therapeutics) for the treatment of gastric cancer. As an allogeneic or "off-the-shelf" product, this therapy utilizes T-cells derived from healthy donors rather than the patient's own cells, which allows for large-scale manufacturing and immediate availability. The T-cells are engineered to express a chimeric antigen receptor that specifically recognizes Claudin 18.2, a tight junction protein that is highly and aberrantly expressed in gastric tumors but has restricted expression in normal tissues. Upon binding to Claudin 18.2 on the surface of gastric cancer cells, the U-CART cells are activated to mediate direct tumor cell lysis and immune-mediated destruction.
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