China-based IASO Biotherapeutics has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for Fucaso (equecabtagene autoleucel), a BCMA-directed CAR-T cell therapy targeting refractory systemic myasthenia gravis (MG). Earlier this year, IASO began a clinical trial for Fucaso in China for the same indication.
Equecabtagene autoleucel is an autologous CAR-T therapy utilizing a lentiviral vector that incorporates a CAR structure with a fully human single-chain variable fragment (scFv), CD8a hinge and transmembrane domains, along with 4-1BB co-stimulatory and CD3ζ activation domains. The therapy was granted marketing approval in China in June 2023 for the treatment of relapsed/refractory multiple myeloma (r/r MM) in patients who have undergone at least three prior lines of therapy, including both a proteasome inhibitor and an immunomodulatory agent.- Flcube.com
