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FIRICABTAGEN AUTOLEUCEL
FIRICABTAGÉN AUTOLEUCEL
AUTOLOGOUS T LYMPHOCYTES OBTAINED FROM PERIPHERAL BLOOD BY LEUKAPHERESIS, TRANSDUCED WITH A SELF-INACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING HUMAN CD22. THE EXPRESSED TRANSGENE COMPRISES THE GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR RECEPTOR SUBUNIT ALPHA (GMCSFR-ALPHA) SIGNAL SEQUENCE, AN ANTI-CD22 SINGLE CHAIN VARIABLE FRAGMENT (SCFV), A CD8ALPHA HINGE AND TRANSMEMBRANE DOMAIN, A 4-1BB COSTIMULATORY DOMAIN AND CD3ZETA PRIMARY STIMULATORY DOMAIN, UNDER CONTROL OF THE HUMAN ELONGATION FACTOR 1 ALPHA (EF-1ALPHA) PROMOTER. ... PROPOSED INN: LIST 129, RECOMMENDED INN: LIST 91