(INND)
ZEVORKABTAGEN AUTOLEUCEL(INNC)
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A SELF-INACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING B-CELL MATURATION ANTIGEN (BCMA, TNFRSF17, CD269). THE EXPRESSED TRANSGENE COMPRISES THE ANTI-BCMA SINGLE-CHAIN VARIABLE FRAGMENT (SCFV), A CD8ALPHA HINGE AND TRANSMEMBRANE (TM) DOMAIN, A 4-1BB COSTIMULATORY DOMAIN, A CD3ZETA DOMAIN AND IS UNDER CONTROL OF THE ELONGATION FACTOR 1 ALPHA (EF1ALPHA) PROMOTER. THE CONSTRUCT IS FLANKED BY 5' AND 3' LONG TERMINAL REPEATS (LTRS) AND ALSO CONTAINS A PSI PACKAGING SIGNAL, A REV RESPONSE ELEMENT (RRE), A CENTRAL POLYPURINE TRACT (CPPT) SEQUENCE AND THE WOODCHUCK HEPATITIS VIRUS POST-TRANSCRIPTIONAL REGULATORY ELEMENT (WPRE). THE T CELLS ARE CULTURED IN THE PRESENCE OF GROWTH MEDIUM CONTAINING IL-2 AND ACTIVATED USING ANTI-CD3 AND ANTI-CD28 ANTIBODIES...; PROPOSED INN: LIST 125, RECOMMENDED INN: LIST 87(WHO)
ZEVORCABTAGENUM AUTOLEUCELUM(INN)