REACT-01: Reversing Autoimmunity Through Cell Therapy

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.

NCT Number	NCT06465147
Lead Sponsor	Seattle Children's Hospital
Conditions	Systemic Lupus Erythematosus
Enrollment	12 participants
Start Date	2024-12-16
Primary Completion	2028-10 (estimated)
Study Completion	2041-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-12