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

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.

NCT Number	NCT06710717
Lead Sponsor	National University of Malaysia Collaborators: Plutonet Sdn Bhd
Conditions	Systemic Lupus Erythematous (SLE)
Enrollment	5 participants
Start Date	2025-01-03
Primary Completion	2028-12-02 (estimated)
Study Completion	2029-01-02 (estimated)
Updated on ClinicalTrials.gov	2025-05-29