← Back to Search

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

SLE-001 Trial 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.Check my eligibility

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.See study design

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.

SLE-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with systemic lupus erythematosus (SLE).

Select...

My blood test shows I have specific antibodies related to my condition.

SLE-001 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)

Secondary outcome measures

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

SLE-001 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Descartes-08

2018

Completed Phase 2

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cartesian TherapeuticsLead Sponsor

8 Previous Clinical Trials

218 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates still eligible to participate in this ongoing clinical trial?

"Indeed, information on clinicaltrials.gov indicates that this investigation is currently enrolling subjects. The trial was initially posted on February 12th, 2024 and most recently revised on February 27th, 2024. Specifically, the study aims to recruit 30 participants from a single site."

Answered by AI

What is the current number of individuals involved in this research endeavor?

"Indeed, the information available on clinicaltrials.gov highlights that this investigation is actively seeking volunteers. The trial was initially listed on February 12, 2024, and was most recently updated on February 27, 2024. This study aims to enroll 30 participants at a single designated site."

Answered by AI

Has Descartes-08 been granted approval by the FDA?

"In this Phase 2 trial, Descartes-08 scored a 2 for safety based on current data available. Efficacy data is still pending at this stage of evaluation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Descartes-08 for Patients With Systemic Lupus Erythematosus

2024. "Descartes-08 for Patients With Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038474.

All > Systemic Lupus Erythematosus > Lupus