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March 15, 2024
FDA Authorizes First CAR-T Cell Clinical Trial for Children with Lupus
The Food & Drug Administration (FDA) has granted Seattle Children’s Hospital the authorization to launch the first CAR-T cell clinical trial in the U.S. for children under 18 years old with systemic lupus erythematosus (SLE).
CAR-T cells are genetically altered cells that are designed to reset the immune system. CAR-T cell therapy targets B cells, which are immune system cells involved in the production of autoantibodies and lupus disease activity. The trial, Reversing Autoimmunity through Cell Therapy, or REACT-01, is planned to begin summer 2024.
Continue to follow the Lupus Foundation of America for updates on REACH-01, as well as other lupus drug development news. Learn more about participating in clinical trials.
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