Descartes-08 for Patients With Systemic Lupus Erythematosus

NCT06038474 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DC08-SLE-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Keywords

Descartes-08; CART; CAR-T; Autoimmune; Auto-antibody; Auto antibody; chimeric antigen receptor; T cells; Lupus; SLE; Lupus Erythematosus; Systemic Lupus Erythematosus; LE

Outcome Measures

Primary Outcomes (1)

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

  Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia.

  Day -59 to Day 50

Secondary Outcomes (4)

• Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

  Day -59 to Month 12

• Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)

  Day -59 to Month 12

• Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)

  Day -59 to Month 12

• Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)

  Day -59 to Month 12

Study Arms (1)

Descartes-08

OTHER

Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Drug: Descartes-08

Interventions

Descartes-08 DRUG

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

Descartes-08

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cartesian Therapeutics: lead

Study Sites (1)

Profound Research LLC

Oceanside, California, 92056, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)