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.
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Single group
CD19 CAR-T cells
Biological/VaccineStudy participant will be given single infusion of autologous CD19 CAR-T cells following lymphodepletion chemotherapy
Rate of Adverse events
Incidence of adverse event (AE), classified according to CTCAE version 5.0, and evaluation and classification of Cytokine Release Syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS)
SLEDAI Remission Rate
Remission is evaluated by fulfilment of SLEDAI remission criteria
Clinical Response Rate
Measured by BILAG, PGA, SLICC/ACR
Rate of B cell aplasia
Numbers of B cells in peripheral blood measured by flow cytometry
Rate of Immunological response
Changes in the levels of SLE-associated serum autoantibodies
Mean of Quality of life score
Quality of life Assessed by FACIT-F
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MalaysiaClick on the lead sponsor to view all of their trials.
National University of Malaysia
Lead sponsor
Plutonet Sdn Bhd
Collaborator
