CSPC Group Starts Phase I Trial of SYS6063, World's First mRNA-LNP CAR-T Therapy for SLE
CSPC Group has initiated a Phase I clinical trial of SYS6063, a chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19 and BCMA, for relapsed or refractory systemic lupus erythematosus (SLE). The trial has started at the first center in China. SYS6063 is the world's first CAR-T product based on LNP-mRNA transfection to receive approval for an SLE clinical trial. The therapy uses lipid nanoparticles to deliver mRNA encoding CD19 and BCMA CARs into T cells, enabling simultaneous expression of both CAR proteins to eliminate autoantibody-secreting cells. No CAR-T therapy has yet been approved for SLE globally.
CSPC Group announced in a filing to the Hong Kong Stock Exchange that the Phase I clinical trial of SYS6063, developed by the company for the treatment of relapsed or refractory systemic lupus erythematosus (SLE), has officially commenced at the first center in China. The product is currently the world's first CAR-T product based on LNP-mRNA transfection targeting CD19 and BCMA to receive approval for an SLE clinical trial.
The product uses lipid nanoparticles (LNP) to transfect T cells with mRNA encoding CARs for CD19 and BCMA, enabling simultaneous expression of two complete CAR proteins to effectively kill CD19- and BCMA-positive cells that secrete autoreactive antibodies. Currently, no CAR-T therapy has been approved for the treatment of SLE worldwide.
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