Evaluating Descartes-08 for treating Systemic Lupus Erythematosus
Descartes-08 for Patients With Systemic Lupus Erythematosus
This study is testing a new CAR T-cell treatment called Descartes-08 to see if it can help adults with active Systemic Lupus Erythematosus who are not getting better with current medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cartesian Therapeutics Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 1 site (Oceanside, California) |
| Trial ID | NCT06038474 on ClinicalTrials.gov |
What this trial studies
This Phase II study aims to assess the safety, tolerability, and manufacturing feasibility of Descartes-08 CAR T-cells in patients diagnosed with Systemic Lupus Erythematosus (SLE). Participants must be adults experiencing active symptoms despite ongoing immunosuppressive treatments. The study will involve monitoring the effects of the CAR T-cell therapy on the disease's progression and symptom management.
Who should consider this trial
Good fit: Ideal candidates are adults with active SLE symptoms who have not responded adequately to multiple immunosuppressive therapies.
Not a fit: Patients with severe lupus nephritis or significant neurological symptoms related to SLE may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with difficult-to-manage SLE.
How similar studies have performed: While CAR T-cell therapies have shown promise in other autoimmune conditions, this specific application for SLE is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oceanside, California
- Profound Research LLC — Oceanside, California, United States (Recruiting)
Study contacts
- Study coordinator: Study Trial Central Mailbox
- Email: trials@cartesiantx.com
- Phone: 302-648-6497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.