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CAR T-cell Therapy

Descartes-08 for Lupus (SLE-001 Trial)

Phase 2
Recruiting
Research Sponsored by Cartesian Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be at least 18 years of age
Patient must have systemic lupus erythematosus (SLE) at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -59 to day 50
Awards & highlights

Summary

"This trial will test the safety and effectiveness of Descartes-08 CAR T-cells in patients with Systemic Lupus Erythematosus (SLE)."

Who is the study for?
This trial is for adults over 18 with systemic lupus erythematosus (SLE) who still have symptoms despite trying at least two immunosuppressive medications and steroids. They must also have specific autoantibodies present in their blood.
What is being tested?
The study is testing the safety, how well patients can tolerate, and the production process of a CAR T-cell therapy called Descartes-08 in people with SLE to see if it's feasible as a treatment option.
What are the potential side effects?
While not explicitly listed, CAR T-cell therapies like Descartes-08 may cause immune system reactions, fever, fatigue, headache, or difficulty breathing among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with systemic lupus erythematosus (SLE).
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My blood test shows I have specific antibodies related to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -59 to day 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -59 to day 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
Secondary study objectives
Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)
Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)
Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Descartes-08Experimental Treatment1 Intervention
Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

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Who is running the clinical trial?

Cartesian TherapeuticsLead Sponsor
8 Previous Clinical Trials
166 Total Patients Enrolled
~19 spots leftby Nov 2025
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