China-based BriSTAR Immunotech has received US regulatory clearance for its Investigational New Drug (IND) application to evaluate YTS109, a site-specific integrated allogeneic CD19 STAR-T cell therapy, in patients with autoimmune haemolytic anaemia (AIHA).

YTS109 leverages the proprietary Synthetic T-Cell Receptor and Antigen Receptor (STAR-T) platform, which fuses CAR antigen recognition with natural TCR signalling to enhance tissue infiltration, sensitivity, and safety while reducing off-target activation. The product uses CRISPR-based editing for precise integration at the TCR locus, avoiding random viral insertion risks and enabling scalable, off-the-shelf manufacturing.

Prior exploratory data in severe autoimmune diseases showed YTS109 achieved 100% complete remission rates in AIHA and sustained responses over 18 months in systemic lupus erythematosus (SLE) with lupus nephritis. The milestone follows BriSTAR's recent RMB 200 million (USD 30 million) Series C financing and reinforces the global regulatory recognition of its universal cell therapy platform beyond oncology into autoimmune indications. The company continues to advance both ex vivo STAR-T and in vivo modalities.