This study focuses on people with diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disease that causes hardening of the skin and can affect internal organs. The main treatment being tested is rapcabtagene autoleucel (also known as YTB323), which is a type of cell therapy where a patient’s own immune cells are modified to fight the disease. This treatment will be compared to rituximab, which is an existing medication used to treat autoimmune conditions.
The purpose of this research is to determine if rapcabtagene autoleucel is more effective than rituximab in treating severe dcSSc that has not responded well to previous treatments. Before receiving the main treatment, patients may receive preparation medications including cyclophosphamide, fludarabine phosphate, and tocilizumab. All medications will be given through an intravenous line directly into the bloodstream.
Throughout the study, which lasts for 52 weeks, doctors will monitor changes in lung function, skin thickness, and ability to perform daily activities. They will also track any side effects that may occur during or after treatment. The study will continue to follow participants for several years to understand the long-term effects of the treatment.



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