Descartes-08 for Patients With Systemic Lupus Erythematosus (SLE-001)

Cartesian Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Systemic Lupus Erythematosus (SLE)

Treatments

Drug: Descartes-08

Study type

Interventional

Funder types

Industry

Identifiers

NCT06038474

DC08-SLE-001

Details and patient eligibility

About

This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.