Study of Universal CD19-targeting CAR-b3b4 T Cell Therapy for Adults with Difficult-to-Treat Autoimmune Diseases

What this Trial Is About

Autoimmune diseases include a range of conditions such as systemic lupus erythematosus, Sjgrens syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis, and antiphospholipid syndrome. These diseases result from the immune system attacking the bodys own tissues, causing damage that can affect quality of life and sometimes be life-threatening. Current treatments involve glucocorticoids, immunosuppressants, and biologics, but researchers are exploring new therapies targeting B cells, which play a key role in these diseases. This clinical study evaluates the safety and effectiveness of universal CD19-targeting CAR- T cells QH103 as a treatment for refractory autoimmune diseases. This cell therapy uses engineered immune cells designed to target B cells involved in disease processes. The study includes adults aged 18 to 80 years with refractory autoimmune diseases who have not responded well to conventional treatments. Participants receive anti-CD19 CAR- T cell therapy and are monitored closely. Participants will be followed for up to 12 months to assess safety and determine the maximum tolerated dose of the therapy within the first 28 days. Disease activity will be measured at months 3, 6, 9, and 12 using various clinical scores specific to each autoimmune condition. Researchers will also monitor immune response, pharmacokinetics, and any disease improvements. The study involves regular blood tests, imaging, and questionnaires to evaluate treatment effects and participant health throughout the trial period.

Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases