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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06038474
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : February 12, 2024
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038474


Contacts
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Contact: Study Trial Central Mailbox 302-648-6497 trials@cartesiantx.com

Locations
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United States, California
Profound Research LLC Recruiting
Oceanside, California, United States, 92056
Sponsors and Collaborators
Cartesian Therapeutics
More Information
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT06038474    
Other Study ID Numbers: DC08-SLE-001
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cartesian Therapeutics:
Descartes-08
CART
CAR-T
Autoimmune
Auto-antibody
Auto antibody
chimeric antigen receptor
 T cells
Lupus
SLE
Lupus Erythematosus
Systemic Lupus Erythematosus
LE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases