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QT-019B is an off-the-shelf, allogeneic CAR-T cell therapy developed by Qihan Biotech for refractory autoimmune diseases, with the lead indication being refractory systemic lupus erythematosus (rSLE). It is derived from leukapheresis products of healthy donors and engineered through multiplex gene editing to express two distinct chimeric antigen receptors targeting both CD19 and BCMA. The product incorporates gene edits to eliminate T-cell receptor (TCR) expression, reduce the risk of graft-versus-host disease, and minimize immunogenicity, thus lowering the risk of host immune rejection. QT-019B is designed to simultaneously clear pathogenic B cells and plasma cells expressing CD19 and BCMA, enabling potent and durable immune reset. In preclinical and investigator-initiated clinical studies, it has shown promising efficacy for multiple refractory autoimmune diseases, with strong persistence and safety in vivo.
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