Descartes-08 for Patients With Systemic Lupus Erythematosus

Eligibility Criteria

• * Patient must be at least 18 years of age.
• * Patient must have systemic lupus erythematosus (SLE) at the time of screening.
• * Active symptoms despite recent or ongoing immunosuppressive therapy with glucocorticoids and at least 2 other immunosuppressive medications being tried for at least 12 weeks within 24 months of screening.
• * At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies detectable at screening as assessed by a CLIA-certified laboratory.
• * Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon resolution of the headache);
• * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
• * Patient is pregnant or lactating.