Back to resultsDescartes-08 for Patients With Systemic Lupus Erythematosus (SLE-001)
Primary Purpose
Systemic Lupus Erythematosus (SLE)
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Descartes-08
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE) focused on measuring Descartes-08, CART, CAR-T, Autoimmune, Auto-antibody, Auto antibody, chimeric antigen receptor, T cells, Lupus, SLE, Lupus Erythematosus, Systemic Lupus Erythematosus, LE
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Descartes-08
Arm Description
Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
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)
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)
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)
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit.
Full Information
NCT ID
NCT06038474
First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Cartesian Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT06038474
Brief Title
Descartes-08 for Patients With Systemic Lupus Erythematosus
Acronym
SLE-001
Official Title
Descartes-08 for Patients With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cartesian Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Descartes-08
Arm Type
Other
Arm Description
Drug: Descartes-08
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
Intervention Type
Drug
Intervention Name(s)
Descartes-08
Intervention Description
Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
Primary Outcome Measure Information:
Title
Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
Description
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.
Time Frame
Day -59 to Day 50
Secondary Outcome Measure Information:
Title
Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Description
Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit.
Time Frame
Day -59 to Month 12
Title
Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)
Description
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at various timepoints up to month 12 follow up visit.
Time Frame
Day -59 to Month 12
Title
Quantify the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)
Description
Assessment of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at various timepoints up to month 12 follow up visit.
Time Frame
Day -59 to Month 12
Title
Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)
Description
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit.
Time Frame
Day -59 to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Descartes-08 for Patients With Systemic Lupus Erythematosus
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