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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -59 to day 50

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)

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