A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

Inclusion criteria

• ✓. Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria；
• ✓. Meet at least one of the following: positive antinuclear antibody (ANA) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening；
• ✓. Had an inadequate response or relapse after standard therapy, defined as any of the following (alone or combined): glucocorticoids, antimalarials (hydroxychloroquine), immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine), or biologics (rituximab, belimumab, telitacicept). Each regimen must have been administered for ≥3 months, and the subject must have received ≥2 immunosuppressants and/or biologics；
• ✓. At screening, meet SLEDAI-2000 ≥7 and have at least one BILAG A or two BILAG B organ domain scores；
• ✓. Prior to the first dose, subjects must have received glucocorticoids and/or antimalarials and/or immunosuppressants for ≥12 weeks, with stable doses for ≥30 days；
• ✓. If receiving oral glucocorticoids (e.g., prednisone), the dose must be ≤40 mg/day at screening and during the screening period；
• ✓. If using glucocorticoids alone, the dose must be ≥7.5 mg/day prednisone (or equivalent).
• ✓. Diagnosed with possible or definite IIM per the 2017 EULAR/ACR classification criteria (≥5.5 points without biopsy; ≥6.7 points with biopsy) ；