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Allogeneic CD19-directed CAR T cells (lentiviral vector) is an investigational off-the-shelf cellular immunotherapy developed by Ospedale Pediatrico Bambino Gesù. Unlike autologous CAR-T therapies, this product utilizes T cells from healthy third-party donors, which are engineered using a lentiviral vector to express a chimeric antigen receptor (CAR) specific for the CD19 antigen. CD19 is a transmembrane protein ubiquitously expressed on B-lineage cells and is a validated target for B-cell malignancies such as acute lymphoblastic leukemia (B-ALL). To address the inherent risk of Graft-versus-Host Disease (GvHD) in the allogeneic setting, the construct incorporates an inducible Caspase 9 (iC9) safety switch. This suicide gene allows for the rapid elimination of the CAR T cells upon administration of a small-molecule dimerizer (rimiducid), providing a pharmacological control mechanism to manage severe toxicities or GvHD. The therapy is primarily being evaluated for pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
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