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Zorpocabtagene autoleucel (Zorpo-cel, MB-CART19.1) is an autologous, CD19-directed chimeric antigen receptor (CAR) T-cell therapy developed by Miltenyi Biomedicine. It is manufactured using a fully automated, closed, and GMP-compliant CliniMACS Prodigy system. The CAR construct is a second-generation CD19-directed CAR containing an FMC63-based single-chain variable fragment (scFv) targeting domain, a CD8 hinge region, a TNFRSF19 transmembrane domain, a 4-1BB (CD137) costimulatory domain, and a CD3-zeta activation domain. It is being developed for the treatment of B-cell malignancies (such as diffuse large B-cell lymphoma, acute lymphoblastic leukemia, and non-Hodgkin lymphoma) and various B-cell-mediated autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), autoimmune hemolytic anemia (AIHA), immune thrombocytopenia (ITP), and antiphospholipid syndrome (APLAS).
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