Descartes-08 for Patients With Systemic Lupus Erythematosus

Launched by CARTESIAN THERAPEUTICS · Sep 8, 2023

Keywords

ClinConnect Summary

The Descartes-08 clinical trial is studying a new treatment called Descartes-08 CAR T-cells for patients with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks healthy tissues. This is a Phase II study, which means researchers are focusing on how safe and tolerable this treatment is, as well as how it can be manufactured. The trial is currently recruiting participants who are at least 18 years old and have active SLE symptoms, even after trying other medications. To qualify, participants need to have specific antibodies present in their blood, indicating ongoing disease activity.

If you decide to participate, you can expect to be closely monitored for your safety throughout the trial. It’s important to note that not everyone with SLE will qualify; for example, those with severe kidney or brain involvement from lupus, or those who are pregnant or breastfeeding, cannot participate. This trial offers a potential new option for those struggling with their symptoms despite existing treatments, and it aims to contribute valuable information about this innovative approach to managing SLE.

Gender

ALL

Eligibility 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.