Study on IMPT-514 in Active Refractory Lupus (SLE)
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in patients with active, refractory lupus nephritis and systemic lupus erythematosus. IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual patients will remain in the active post-treatment period for approximately 1 year. Participants will continue in long-term follow-up for 15 years from treatment.
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 Lupus Nephritis
🗓️ Study Start (Actual) 15 February 2024
🗓️ Primary Completion (Estimated) February 2027
✅ Study Completion (Estimated) February 2027
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Los Angeles, California, United States
📍 San Francisco, California, United States
📍 Iowa City, Iowa, United States
📍 Detroit, Michigan, United States
📍 Cincinnati, Ohio, United States
📍 Westmead, Australia

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Willing and able to provide written informed consent
    • 2. Age 18 years of age or older
    • 3. Weight \> 45 kg at enrollment
    • 4. Adequate blood pressure control
    • 5. Diagnosis of SLE by 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, including positive ANA or positive anti-dsDNA
    • 6. LN participants: Active, biopsy-proven, proliferative lupus nephritis Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
    • Other protocol-defined criteria apply.

    Exclusion Criteria:

    • 1. Any clinically significant underlying illness, other than SLE and LN, which would pose a safety risk or concern, as determined by the Investigator
    • 2. Any other systemic autoimmune condition
    • 3. Rapidly progressive glomerulonephritis
    • 4. Active central nervous system (CNS) lupus
    • 5. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
    • Other protocol-defined criteria apply.
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 22 November 2023
  • First Submitted that Met QC Criteria 22 November 2023
  • First Posted 1 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2024
  • Last Update Posted 31 May 2024
  • Last Verified May 2024