drugset / Trial / NCT06710717

Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)

NCT06710717

NaSingle-groupOpen-labelTreatment

Summary

This pilot clinical study aims to evaluate the effectiveness of Chimeric Antigen Receptor (CAR) T-cell therapy in treating severe, refractory systemic lupus erythematosus (SLE), an autoimmune disease driven by autoreactive B-cells. Current treatments for severe SLE, including glucocorticoids, cytotoxic, and immunosuppressive drugs, have significant limitations. These treatments do not adequately control the underlying autoimmune process and require long-term use, leading to chronic side effects and often failing to prevent permanent organ damage. Given the high prevalence and mortality rates associated with SLE in regions like Asia and Malaysia, there is a pressing need for more effective therapies.

Timeline

Start
2025-01-03
Primary completion
2028-12-02
Completion
2029-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19 CAR-T cells Cell therapy Intravenous