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TI-0032 (also known as TI-0032-III) is an investigational, off-the-shelf, in vivo chimeric antigen receptor T-cell (CAR-T) therapy developed by Therorna (Yuanyin Biotechnology). It is designed to treat relapsed and refractory B-cell-mediated autoimmune diseases, such as systemic lupus erythematosus (SLE), Sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and ANCA-associated systemic vasculitis, as well as B-cell malignancies. The therapy utilizes a T-cell-targeted lipid nanoparticle (tLNP) delivery system conjugated with a humanized antibody fragment to deliver a circular RNA (circRNA) payload encoding an anti-CD19 CAR directly to T cells in vivo. This approach allows for transient, non-integrating, and re-dosable CAR-T cell generation in situ, bypassing the complex ex vivo manufacturing process of conventional CAR-T therapies.
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