Descartes-08 for Patients With Systemic Lupus Erythematosus (NCT06038474) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Descartes-08 for Patients With Systemic Lupus Erythematosus
United States6 participantsStarted 2024-02-12
Plain-language summary
This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
Who can participate
Age range18 Years
SexALL
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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 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.
Exclusion Criteria:
* 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.
What they're measuring
1
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)