Shiyao Group (01093): Phase I clinical trial of SYS 6063 to treat recurrent refractory systemic lupus erythematosus was officially launched at the first center in China

Zhitong Finance App News, Shiyao Group (01093) announced that the phase I clinical trial of SYS6063 developed by the group to treat recurrent refractory systemic lupus erythematosus (SLE) has been officially launched at the first center in China.

This product is currently the world's first chimeric antigen receptor T cell (CAR-T) product targeting CD19/bCMA based on LNP-mRNA transfection that has been approved for SLE clinical trials. The product uses lipid nanoparticles (LNP) to transfect CD19 and BCMA-expressing carmRNA into T cells to simultaneously express two complete CAR proteins, thereby effectively killing CD19 and BCMA-positive cells that secrete autoreactive antibodies. It is expected to provide a novel, safe, and effective potential treatment option for SLE patients. Currently, no CAR-T therapy has been approved to treat SLE globally.

Compared with traditional CAR-T products, this product has the advantages of high cell viability, high CAR positivity rate, no risk of tumorigenesis due to no genomic integration, and low incidence of adverse reactions such as cytokine release syndrome (CRS). Preclinical studies have shown that this product can significantly kill CD19 and BCMA antigen-positive tumor cells, and has shown good safety. In terms of cost, using LNP to transfect T cells can reduce the high cost of using lentiviral vectors and effectively reduce the financial burden on patients.

Previously, the group had received the “Drug Clinical Trial Approval Notice” issued by the State Drug Administration of the People's Republic of China in June 2026, and initiated phase I clinical trials of this product for the treatment of SLE after approval. This phase I clinical trial is a single-arm, open, two-stage (dose escalation and dose expansion), multi-center clinical study conducted in patients with recurrent refractory SLE. It aims to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of this product in patients with SLE. Currently, the recruitment and screening of test subjects is being actively promoted.