eligibility_summary
Include: M/F 2–30 (staggered: adults→teens→children), active, refractory SLE, apheresis available, washouts: ≥24 wks rituximab, ≥12 wks belimumab/anifrolumab, ≥4 wks calcineurin, stable non‑calcineurin IS ≥8 wks, adequate organs/labs, contraception 12 mos, stay within 1‑hr of Seattle Children’s 4 wks. Exclude: CNS lupus, dialysis, pregnancy/breastfeeding, COPD/>10 pack‑yrs/O2 sat ≤92%, IgG intolerance, malignancy unless treated & disease‑free, solid organ transplant, severe infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: REACT-01 (NCT06465147), Phase 1, open-label, single-arm in refractory SLE (pediatric/young adults). Intervention: SCRI-CAR19v3, an autologous, gene-modified cellular therapy (CD19-directed CAR T cells) made from the patient’s T cells and given as a single infusion. Mechanism of action: The CAR confers specificity to CD19, upon engaging CD19 on B cells, the engineered T cells activate and kill CD19+ cells via cytotoxicity, depleting circulating and tissue-resident B cells and aiming to reset humoral autoimmunity and reduce autoantibody production. Targets: CD19+ B-lineage cells (naive, memory, plasmablasts), pathways tied to B-cell receptor–mediated autoimmunity and B–T cell costimulation.