Leman Biotech treats first systemic lupus erythematosus patient

Patient Details

• Gender & Age range: Female, Aged 20-30
• Condition: Type V Lupus Nephritis (a severe form of SLE)
• Prior Treatment: Multiple hormones and monoclonal antibodies, with suboptimal therapeutic outcomes
• Side Effects of Previous Treatment: Long-term use of corticosteroids led to facial and body swelling

Treatment Summary
In February 2025, the patient enrolled in the IIT clinical study received a single ultra-low-dose Meta 10-19 infusion (only 1‰ of the conventional dose) at the First Affiliated Hospital of Zhejiang University School of Medicine. Post treatment, the patient showed marked improvement in overall health, with significant reductions in indicators related to lupus nephritis. The treatment demonstrated excellent safety, with no serious cytokine release syndrome (CRS) or significant immune effector cell-associated neurotoxicity syndrome (ICANS) observed.

Post-infusion, the patient was able to discontinue all SLE-related medications and was clinically assessed to have achieved “medication-free DORIS remission.” This outcome suggests the potential for CD19 CAR-T therapy to provide a one-time cure for SLE, representing substantial clinical and societal value.

Unmet needs in SLE Treatment
The ultimate goal in treating SLE is achieving remission—the complete elimination of disease activity without the need for maintenance medication. However, current therapies rarely accomplish this goal. According to a SPOCS 3-year prospective cohort study, fewer than 8% of patients reached DORIS remission. Similarly, a post hoc analysis of a multicenter trial of an approved biologic monoclonal antibody therapy showed only 8% achieved DORIS remission at week 52, highlighting the limitations of existing therapies.

The Promise of CAR-T in Autoimmune Disease
Unlike conventional therapies, CAR-T cell therapy holds the promise of a revolutionary breakthrough in SLE treatment by targeting and eliminating pathogenic B cells. Some patients can achieve complete remission without the need for any corticosteroids or immunosuppressants, with outcomes approaching a “one-time cure.” This represents a transformative advancement with the potential to reduces long-term drug toxicity, lower healthcare costs, and deliver profound clinical value and societal impact.

Definition of DORIS Remission
DORIS remission (Definition Of Remission In SLE) is a clinically recognized standard to define a state where lupus disease activity is significantly reduced or fully controlled. Its definition integrates clinical indicators, laboratory parameters, and patient-reported outcomes. Traditionally, DORIS remission allows the use of low-dose medications and is not truly medication-free. However, with innovative CAR-T therapies like Meta 10-19, patients may now achieve true medication-free remission, a shift toward functional cure in SLE.