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REACT-01: Reversing Autoimmunity Through Cell Therapy
This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research patients with treatment-refractory Lupus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR) A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.
Conditions:
🦠 Systemic Lupus Erythematosus
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) July 2028
✅ Study Completion (Estimated) July 2041
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2
    • * Serologically active Systemic Lupus Erythematosus that is refractory to treatment
    • * Able to tolerate apheresis or already has an apheresis product available for use in manufacturing.
    • * ≥ 24 weeks post last Rituximab or related B cell depleting therapy
    • * ≥ 12 weeks post last Belimumab / Anifrolumab therapy
    • * ≥ 4 weeks post last calcineurin inhibitor treatment
    • * For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment
    • * For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment
    • * Adequate organ function
    • * Adequate laboratory values
    • * Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
    • * Subjects must be willing to remiain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion.
    • * Subject and/or legally authorized representative has signed the informed consent form for this study

    Exclusion Criteria:

    • * History or presence of active CNS lupus or other CNS disease
    • * Kidney dysfunction requiring renal replacement therapy
    • * Pregnant or breastfeeding
    • * Insufficient pulmonary reserve including history of COPD, \>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air
    • * Unable to tolerate repletion with any formulation of IgG.
    • * Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment.
    • * Prior solid organ transplantation.
    • * Presence of an active severe infection
    • * Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Ages Eligible for Study: 2 Years to 30 Years (CHILD, 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 13 June 2024
  • First Submitted that Met QC Criteria 13 June 2024
  • First Posted 18 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 20 June 2024
  • Last Verified June 2024