Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus

This is a single-center, open-label, non-randomized, Phase I/II trial. Patients with refractory systemic lupus erythematosus (SLE) will receive CD19 CAR T cells. The primary objective is to learn about the safety and tolerability of CD19 CAR T cell therapy in subjects with refractory SLE and to determine the optimal biological dose (OBD) and recommend phase 2 dose (RP2D) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with refractory SLE in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 28 days after CD19 CAR T-cell infusion in phase I and overall response rate (ORR) in phase II. A total number of 18 subjects will be enrolled.