Status:
ACTIVE_NOT_RECRUITING
Descartes-08 for Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Cartesian Therapeutics
Conditions:
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06038474
Start Date
February 12 2024
End Date
November 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
Profound Research LLC
Oceanside, California, United States, 92056