Descartes-08 for Patients With Systemic Lupus Erythematosus

Phase 2

Recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: Descartes-08

• Registration Number: NCT06038474
• Lead Sponsor: Cartesian Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-14
• Status Verified: 2024-02
• Study Start: 2024-02-12
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)	Day -59 to Day 50	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.

Secondary Outcome Measures

Name	Time	Method
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	Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)	Day -59 to Month 12	Assessment of whether participants meet the Systemic Lupus Erythematosus Responder Index (SRI) criteria (Yes/No) at various timepoints up to month 12 follow up visit.
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	Assessment of whether participants meet the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) criteria (Yes/No) at various timepoints up to month 12 follow up visit.
Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)	Day -59 to Month 12	Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity.

Trial Locations

Locations (1)

Profound Research LLC; 🇺🇸 Oceanside, California, United States