SLE-001: Descartes-08 for Patients With Systemic Lupus Erythematosus

Sponsor

Cartesian Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06038474

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus (SLE)	Drug: Descartes-08	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Descartes-08 for Patients With Systemic Lupus Erythematosus

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Descartes-08 Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA	Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA

Arm

Intervention/Treatment

Other: Descartes-08

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

Drug: Descartes-08

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

Outcome Measures

Primary Outcome Measures

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

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.
Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI) [Day -59 to Month 12]
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at various timepoints up to month 12 follow up visit.
Quantify 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 British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.