This clinical trial is focused on studying two challenging diseases: rheumatoid arthritis and Sjögren’s disease. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. Sjögren’s disease is another immune system disorder that primarily affects the glands that produce tears and saliva, but in severe cases, it can involve other organs. The study will explore the effects of a new treatment called rapcabtagene autoleucel, also known by its code name YTB323. This treatment is a type of cell therapy, which involves using specially modified cells to target and treat the disease.
The purpose of the study is to assess the safety of rapcabtagene autoleucel in participants with difficult-to-treat rheumatoid arthritis and severe, refractory Sjögren’s disease with organ involvement. Participants will receive the treatment through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will also involve monitoring the behavior of the treatment in the body, known as cellular kinetics, to understand how it moves and changes over time.
In addition to rapcabtagene autoleucel, the study will also involve the use of other medications, including tocilizumab, fludarabine phosphate, and cyclophosphamide. These medications are commonly used in treating autoimmune diseases and will be administered as part of the study protocol. Some participants may receive a placebo instead of the active treatment. The study aims to gather information over a period of time to evaluate the treatment’s safety and its potential effectiveness in managing these complex diseases.



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