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This autologous CD19-targeted CAR-T cell therapy is an investigational biologic being developed by Shenzhen Cell Valley for the treatment of relapsed or refractory autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis, inflammatory myopathy, and immune thrombocytopenia. The therapy utilizes a patient's own T cells, which are engineered via retroviral vector transduction to express a chimeric antigen receptor (CAR) specific for CD19, a surface antigen prevalent on B cells and plasmablasts. The CAR construct features an anti-CD19 single-chain variable fragment (scFv) derived from the FMC63 clone, a CD8-derived hinge and transmembrane region, a CD28 co-stimulatory domain, and a CD3ζ signaling domain. By inducing deep depletion of B cell lineages, the therapy aims to eliminate the source of autoantibodies and reset the immune system, potentially leading to long-term clinical remission and the discontinuation of conventional immunosuppressive therapies.
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