Systemic lupus erythematosus (SLE) is often viewed as the “cancer of autoimmune diseases” - patients face limited efficacy with immunosuppressants, high relapse rates, and significant social burdens. While autologous CD19 CAR-T therapies have shown benefit, they are limited by personalized manufacturing, high costs, and risks from random genomic insertion.

Prof. Huji Xu, Prof. Xin Lin, and BriSTAR Immunotech are breaking new ground with YTS109, a hypoimmune allogeneic T cell product engineered using CRISPR-Cas9 to knock out TRAC, PD1, HLA-A, HLA-B and CIITA, with a CD19-targeting synthetic TCR and antigen receptor (STAR) precisely integrated into the TRAC locus to enable physiological, TCR-like signaling. In five patients with severe, refractory SLE and lupus nephritis, YTS109 was well tolerated and produced remarkable results: 100% SRI-4 response sustained through 6 months, rapid disease activity reduction, improved quality of life, and renal tissue restoration. Published in Nature Medicine: Allogeneic CD19-targeting T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial | Nature Medicine

A major step forward for off-the-shelf cell therapy in autoimmunity. As BriSTAR’s former investor, I’m proud to see such bold science translating into meaningful hope for patients with refractory lupus nephritis.

—— Wei Peng (Healthcare investor)

Refractory SLE—especially when complicated by severe LN—has long left patients with limited treatment options. As a next-generation allogeneic universal cell therapy, YTS109 demonstrated inspiring efficacy and excellent safety in this exploratory trial. The "immune reset" phenomenon it induces offers a new lens to understand disease remission mechanisms. We anticipate its future development will transform clinical practice and usher in a new era of precision cell therapy for refractory autoimmune diseases.

—— Professor Huji Xu (Principal Investigator, Corresponding Author, The Changzheng Hospital of Naval Medical University)


This Nature Medicine publication represents a major breakthrough for our STAR-T platform in autoimmune disease applications. YTS109’s success not only overcomes the key limitations of autologous cell therapies—lengthy cycles, high costs, and manufacturing risks—but also brings us closer to shifting autoimmune disease treatment from  "ifelong medication" to "functional cure".  We will accelerate YTS109’s clinical development for lupus and other severe autoimmune conditions to deliver this innovative therapy to patients worldwide.

—— Professor Xin Lin (Scientific Founder of BriSTAR Immunotech, Tsinghua University)