CSPC PHARMA (01093): The Phase I clinical trial of SYS 6063 for the treatment of refractory relapse systemic lupus erythematosus has officially launched at the first center in China.

CSPC PHARMA (01093) announced that the group has officially launched the Phase I clinical trial of SYS6063 for the treatment of refractory systemic lupus erythematosus (SLE) at the first center in China. This product is the worlds first LNP-mRNA-transfection-based CAR-T product targeting CD19/BCMA approved for clinical trials in SLE. It employs lipid nanoparticles (LNP) to transfect CAR mRNA expressing CD19 and BCMA into T cells, enabling the simultaneous expression of two complete CAR proteins, thereby effectively killing CD19 and BCMA positive cells that secrete autoreactive antibodies. This offers a new, safe, and potentially effective therapeutic option for SLE patients. Currently, no CAR-T therapies have been approved worldwide for the treatment of SLE. Compared to traditional CAR-T products, this product has the advantages of high cell viability, high CAR positivity rate, no tumorigenic risk caused by genomic integration, and a lower incidence of adverse reactions such as cytokine release syndrome (CRS). Preclinical studies have shown that this product can significantly kill tumor cells positive for CD19 and BCMA antigens and demonstrates good safety. In terms of cost, using LNP to transfect T cells can reduce the high expenses associated with using lentiviral vectors, effectively alleviating the economic burden on patients. Previously, the group received the "Drug Clinical Trial Approval Notification" issued by the National Medical Products Administration of the People's Republic of China in June 2026 and initiated the Phase I clinical trial of this product for the treatment of SLE after receiving approval. This Phase I clinical trial is a single-arm, open-label, two-stage (dose escalation and dose expansion), multi-center clinical study conducted in patients with refractory SLE, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of the product in SLE patients. Currently, recruitment and screening of subjects are actively underway.