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REACT-01: Reversing Autoimmunity Through Cell Therapy

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Start date changed from estimate of Oct 30, 2024 to Dec 16, 2024
    • Site contact updated
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Jul 2024 to Oct 30, 2024
    • Primary completion date: Jul 2028 to Oct 2028
    • Study completion date: Jul 2041 to Oct 2041
    • Eligibility criteria revised
    • Site details revised
  4. Primary endpoints revised (2)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (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.
Trial Details
NCT Number NCT06465147
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 Systemic Lupus Erythematosus
Related terms Lupus Erythematosus, Systemic
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov