ITEZOCABTAGENE AUTOLEUCEL

UNII:	1T1JX1GA68
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	ITEZOCABTAGENE AUTOLEUCEL
GSRS Full Record:	1T1JX1GA68 i

AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A NON-REPLICATING MOLONEY MURINE LEUKAEMIA VIRUS (MMLV) VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) UNDER THE CONTROL OF THE 5' LONG TERMINAL REPEAT (LTR) MMLV PROMOTER, COMPRISING A SINGLE-CHAIN VARIABLE FRAGMENT DERIVED FROM THE MURINE ANTIBODY HRS3 TARGETING CD30 (TUMOUR NECROSIS FACTOR RECEPTOR SUPERFAMILY MEMBER 8 (TNFRSF8)), AN IGG1 CH2-CH3 SPACER, CD28 TRANSMEMBRANE AND INTRACELLULAR COSTIMULATORY DOMAINS, AND A CD3.ZETA. INTRACELLULAR ACTIVATION DOMAIN. THE T CELLS ARE ACTIVATED IN THE PRESENCE OF ANTI-CD3 AND ANTI-CD28 THEN CULTURED IN THE PRESENCE OF GROWTH MEDIUM CONTAINING HUMAN SERUM, INTERLEUKIN 7 (IL-7) AND IL-15. THE T CELLS ARE CD3+ (70% HISTORICALLY 98% +/-1.7%), ANTI-CD30-CAR (20%), ARE CYTOTOXIC FOR CD30-EXPRESSING CELLS AND CONTAIN <1% OF RESIDUAL B AND NATURAL KILLER (NK) CELLS
itezocabtagene autoleucel [INN]

Note

UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

ITEZOCABTAGENE AUTOLEUCEL

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