CSPC: BCMA/CD19 CAR-T approved for clinical trials
On June 2, CSPC announces that the first mRNA-LNP-based bispecific chimeric antigen receptor (CAR)-T cell injection (SYS6063) developed by the company receives approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials, indicated for relapsed/refractory systemic lupus erythematosus (SLE).
SYS6063 is an mRNA-LNP-based bispecific cell therapy product. It expresses CARs that specifically recognize cluster of differentiation 19 (CD19) and B-cell maturation antigen (BCMA), precisely identifying and eliminating CD19-positive and BCMA-positive cells in patients, thereby achieving the therapeutic goal.
According to CSPC’s press release, the bispecific synergy eliminates pathogenic cells at the source, fundamentally improving patients’ condition and addressing the pain points of traditional treatments that are incurable and prone to relapse. Preclinical studies demonstrate that SYS6063 significantly kills CD19- and BCMA-positive cells and possesses good safety and efficacy.
In addition to systemic lupus erythematosus, SYS6063 also shows potential for treating other B cell/plasma cell-mediated autoimmune diseases such as myasthenia gravis (MG), rheumatoid arthritis (RA), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and can be expanded to hematologic malignancies including relapsed/refractory multiple myeloma (MM) and B-cell lymphoma.
