A Study of CAR-T Cells in Subjects with Systemic Lupus Erythematosus

Launched by WUHAN UNION HOSPITAL, CHINA · Mar 23, 2025

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, between 18 and 65 years old;
• • Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
• • Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
• • SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
• • Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
• • Good organ functions;
• • Voluntary participates this trial and can comprehend and sign ICF.
• Exclusion Criteria:
• • Had or has active malignancy;
• • Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
• • Combined with other autoimmune disease that needs treatment;
• • Pregnant or lactating women;
• • Has other factors that deemed not suitable by investigator.