Descartes-08 for Patients With Systemic Lupus Erythematosus
Running, not enrolling · Phase 2
Conditions studied: Systemic Lupus Erythematosus (SLE)
In brief
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).
Key facts
- Study ID
- NCT06038474
- Run by
- Cartesian Therapeutics
- People needed
- 6
- Starts
- 2024-02-12
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Profound Research LLC — Oceanside, California, United States
Full record on ClinicalTrials.gov
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