drugset / Trial / NCT06465147
REACT-01: Reversing Autoimmunity Through Cell Therapy
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-12-16
- Primary completion
- 2028-10
- Completion
- 2041-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCRI-CAR19v3 | Cell therapy | — | — |