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CNI-Resistant CAR-Tregs v2.2 is an investigational genetically engineered regulatory T cell (Treg) therapy developed by Regatta Bio (formerly Regatta Medical) for the treatment of transplantation-related conditions and autoimmune disorders. The therapy utilizes a proprietary platform to engineer Tregs that are resistant to suppression by calcineurin inhibitors (CNIs), such as tacrolimus and cyclosporine, which are standard-of-care immunosuppressants used after organ transplantation. This modification allows the therapeutic Tregs to maintain their suppressive function and persist in the presence of systemic immunosuppression. Additionally, the cells are engineered for IL-2 independence to enhance survival and persistence without exogenous IL-2 and express a chimeric antigen receptor (CAR) targeting OX40 ligand (OX40L) to improve antigen specificity and control alloreactivity.
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