Descartes-08 for Patients With Lupus
This is a Phase II study to assess the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
Conditions:
🦠 Systemic Lupus Erythematosus (SLE)
🗓️ Study Start (Actual) 12 February 2024
🗓️ Primary Completion (Estimated) 1 November 2025
✅ Study Completion (Estimated) 1 November 2026
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Oceanside, California, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 September 2023
  • First Submitted that Met QC Criteria 8 September 2023
  • First Posted 14 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified February 2024