Descartes-08 for Patients With Systemic Lupus Erythematosus (SLE-001)

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ClinicalTrials.gov Identifier: NCT06038474

Recruitment Status : Recruiting

First Posted : September 14, 2023

Last Update Posted : February 28, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Cartesian Therapeutics

Tracking Information

First Submitted Date ^ICMJE

September 8, 2023

First Posted Date ^ICMJE

September 14, 2023

Last Update Posted Date

February 28, 2024

Actual Study Start Date ^ICMJE

February 12, 2024

Estimated Primary Completion Date

November 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE) [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Day -59 to Month 12 ]
Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Descartes-08 for Patients With Systemic Lupus Erythematosus

Official Title ^ICMJE

Descartes-08 for Patients With Systemic Lupus Erythematosus

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 Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Lupus Erythematosus (SLE)

Intervention ^ICMJE

Drug: Descartes-08

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

Study Arms ^ICMJE

Descartes-08

Drug: Descartes-08

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

Intervention: Drug: Descartes-08

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

November 1, 2026

Estimated Primary Completion Date

November 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Study Trial Central Mailbox

302-648-6497

trials@cartesiantx.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06038474

Other Study ID Numbers ^ICMJE

DC08-SLE-001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Cartesian Therapeutics

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Cartesian Therapeutics

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Cartesian Therapeutics

Verification Date

February 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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