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This is an investigational autologous, second-generation chimeric antigen receptor (CAR) T-cell therapy targeting the CD19 antigen. Developed by the Federal Research Institute of Pediatric Hematology, Oncology and Immunology (also known as the Dmitry Rogachev National Medical Research Center) in Russia, the therapy involves genetically modifying a patient's own T-cells to express a CAR consisting of an anti-CD19 single-chain variable fragment (scFv) linked to a 4-1BB (CD137) costimulatory domain and a CD3-zeta signaling domain. The manufacturing process is notable for utilizing the CliniMACS Prodigy automated system, which allows for standardized, closed-system production. It is primarily being evaluated for the treatment of pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), aiming to induce deep molecular remissions in patients who have exhausted standard-of-care options.
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