FT819 in Moderate to Severe Active Lupus
This is a phase 1 study designed to assess the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in patients with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further assess the safety and activity of FT819.
Conditions:
🦠 Systemic Lupus Erythematosus
🗓️ Study Start (Actual) 28 March 2024
🗓️ Primary Completion (Estimated) 30 September 2027
✅ Study Completion (Estimated) 30 September 2042
👥 Enrollment (Estimated) 32
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Minneapolis, Minnesota, United States
📍 Omaha, Nebraska, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male or female adults ≥18 years and \<40 years of age at the time of signing the informed consent form (ICF).
    • * Diagnosed with SLE by the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
    • * Positivity for antinuclear antibody, anti-ds-DNA antibody, and/or anti-Smith antibody at screening.
    • * Active SLE at screening, as defined by SLEDAI ≥8 points (with a clinical SLEDAI ≥4 points, excluding alopecia, mucosal ulcers, and fever); AND one or more major organ systems with British Isles Lupus Assessment Group (BILAG) A score, excluding musculoskeletal, mucocutaneous, and/or constitutional organ systems.
    • * Failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.

    Exclusion Criteria:

    • * Active neurological symptoms of SLE at screening.
    • * Potentially irreversible organ damage related to SLE, where in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant.
    • * Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment.
    • * Prior treatment with CAR T-cell therapy within the last 6 months, allograft organ transplant, or hematopoietic stem cell transplant.
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 6 March 2024
  • First Submitted that Met QC Criteria 6 March 2024
  • First Posted 13 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024