Study of Single-Dose anti-CD19 CAR T Cell Therapy for Adults With Systemic B Cell Mediated Autoimmune Diseases Including Lupus, Scleroderma, and Myositis

What this Trial Is About

Researchers are investigating an advanced therapy using genetically engineered T cells to target B cells in patients with systemic autoimmune diseases such as Systemic Lupus Erythematosus SLE, Systemic Sclerosis SSc, Dermatomyositis, and Polymyositis. This open-label, non-randomized study evaluates the safety and effects of a single dose of anti-CD19 CAR T cell therapy, designed to combat B cell activity driving these conditions. The study is sponsored by Miltenyi Biomedicine GmbH and includes adults with active disease who have not responded adequately to other treatments. Participants receive a single intravenous infusion of the investigational product, which consists of their own T cells genetically modified to express chimeric antigen receptors targeting CD19 on B cells. Before infusion, patients undergo leukapheresis to collect T cells and receive lymphodepleting chemotherapy to prepare the body. There is no control group all participants receive the active treatment. The study monitors patients for 24 weeks post-infusion to assess clinical and immune responses. During the study, participants will have scheduled visits for safety assessments, laboratory tests, disease activity evaluations, and quality of life questionnaires up to 24 weeks after treatment. Researchers will measure safety outcomes up to 28 days and multiple efficacy and immune response markers throughout the 24-week follow-up. The study involves a thorough evaluation of disease-specific activity, patient and physician assessments, and functional health questionnaires to understand the therapys impact over time.

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease