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Autologous CD19-directed CAR-T cell therapy is an advanced immunotherapy that utilizes a patient's own T lymphocytes, which are genetically engineered ex vivo to express a chimeric antigen receptor (CAR) specific for the CD19 antigen. CD19 is a cell surface protein primarily expressed on B lymphocytes, making it a critical target for treating B-cell malignancies and autoimmune diseases driven by pathogenic B cells, such as systemic lupus erythematosus (SLE). The manufacturing process involves collecting T cells via leukapheresis, transducing them with a viral vector (typically lentiviral) to express the CAR, and expanding them under Good Manufacturing Practice (GMP) conditions. Once re-infused into the patient following lymphodepleting chemotherapy, these CAR-T cells selectively identify and eliminate CD19-positive B cells. This specific program is being evaluated by the University of Sao Paulo in the CLEVER-SLE trial for patients with refractory SLE, with manufacturing conducted at the Ribeirão Preto Blood Center.
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