Descartes-08 for Patients With Systemic Lupus Erythematosus

Inclusion 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 withglucocorticoids and at least 2 other immunosuppressive medications being tried forat least 12 weeks within 24 months of screening.

• At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodiesdetectable at screening as assessed by a CLIA-certified laboratory.

Exclusion Criteria:

• Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptomsof SLE including headache, seizure, psychosis, and organic brain syndrome (a patientwith an incidental headache, deemed unrelated to SLE, may re-screen by telephoneupon resolution of the headache);

• Major chronic illness that is not well managed at the time of study entry and in theopinion of the investigator may increase the risk to the patient.

• Patient is pregnant or lactating.