Descartes-08 for Patients With Systemic Lupus Erythematosus

NCT ID: NCT06038474

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2026-11-01

Brief Summary

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).

Conditions

Systemic Lupus Erythematosus (SLE)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Descartes-08

Drug: Descartes-08

Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Group Type: OTHER

Descartes-08

Intervention Type: DRUG

Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Interventions

Descartes-08

Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cartesian Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Profound Research LLC

Oceanside, California, United States

Countries

United States

Other Identifiers

DC08-SLE-001

Identifier Type: -

Identifier Source: org_study_id