Phase 12 Study of CD19 CAR T Cell Therapy for Patients with Refractory Systemic Lupus Erythematosus

What this Trial Is About

Researchers are investigating the safety and effectiveness of CD19 CAR T cell therapy for treating patients with refractory systemic lupus erythematosus SLE, including those with lupus nephritis LN. This Phase III open-label, non-randomized trial aims to find the best dose and evaluate response rates in this patient group. The study is led by Beijing GoBroad Hospital and will enroll 18 participants aged 3 to 65 years who have not responded to standard treatments. Patients will first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. After this, they will be given a single dose of CD19 CAR T cells. The trial has two phases Phase I focuses on safety and determining the recommended dose, while Phase II will assess how well the treatment works. Treatment effects and side effects will be monitored for up to two years following infusion. Participants will undergo regular assessments including monitoring for dose-limiting toxicities within 28 days post-infusion, adverse events up to two years, and measurements of treatment response at 3 and 6 months. Additional evaluations will include pharmacokinetics and overall survival. Participants will be followed closely to understand the treatments impact and manage any side effects throughout the study duration.

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