NCT06465147

REACT-01: Reversing Autoimmunity Through Cell Therapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	SCRI-CAR19v3	Single infusion of SCRI-CAR19v3

Timeline

• Start date: 2024-12-16
• Primary completion: 2028-10-01
• Completion: 2041-10-01
• First posted: 2024-06-18
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study