(INND)
SATRIKABTAGEN AUTOLEUCEL(INNC)
AUTOLOGOUS T LYMPHOCYTES OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A SELFINACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING HUMAN CLAUDIN 18.2 (ALSO KNOWN AS CLAUDIN 18 ISOFORM A2, CLDN18.2). THE EXPRESSED TRANSGENE COMPRISES ANTI-HUMAN CLDN18.2 SINGLE-CHAIN VARIABLE FRAGMENT (SCFV), DERIVED FROM HUMANIZED MONOCLONAL IGG1 ANTIBODY HU8E5-2I, HUMAN CD8ALPHA HINGE, CD28 TRANSMEMBRANE AND CO-STIMULATORY DOMAIN AND CD3ZETA SIGNALLING 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 A WOODCHUCK HEPATITIS VIRUS POSTTRANSCRIPTIONAL REGULATORY ELEMENT (WPRE); ... PROPOSED INN: LIST 127, RECOMMENDED INN: LIST 89(WHO)
SATRICABTAGENUM AUTOLEUCELUM(INN)