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CD19-CART01 is an autologous, second-generation chimeric antigen receptor (CAR) T-cell therapy designed to target the B-lymphocyte antigen CD19. Developed by the Ospedale Pediatrico Bambino Gesù, this cell therapy is distinguished by the inclusion of an inducible Caspase 9 (iC9) safety switch. The iC9 system consists of a pro-apoptotic gene that can be triggered by the administration of a small-molecule dimerizing agent, facilitating the rapid elimination of the engineered T cells in the event of severe toxicities such as cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). The therapy is primarily investigated for the treatment of pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL).
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