ORVACABTAGENE AUTOLEUCEL

UNII:	K8RW1TW3EM
Formula:
Preferred Substance Name:	ORVACABTAGENE AUTOLEUCEL
GSRS Full Record:	K8RW1TW3EM i

JCARH125
JCARH-125
JCARH125 CONSISTS OF HUMAN CULTURE EXPANDED GENETICALLY MODIFIED AUTOLOGOUS T CELLS FOR CELL-BASED GENE THERAPY. CD4+ CD8+ T CELLS ARE DERIVED FROM ISOLATED BLOOD OF THE PATIENT AND ARE TRANSDUCED WITH NON-REPLICATIVE SELF-INACTIVATING (SIN) LENTIVIRAL VECTOR ENCODING AN MSK54 ANTI-BCMA SINGLE CHAIN VARIABLE FRAGMENT (SCFV), LGG4-CH2-CH3 HINGE REGION, CD28/CD137 (4-1BB), CD3ZETA CHIMERIC ANTIGEN RECEPTOR (CAR) UNDER THE TRANSCRIPTIONAL CONTROL OF A HYBRID PROMOTER CONSISTING OF THE HUMAN TRANSLATION ELONGATION FACTOR 1 ALPHA (EF1ALPHA) PROMOTER AND THE R REGION PLUS PART OF THE U5 REGION FROM THE HUMAN T-CELL LEUKEMIA VIRUS (HTLV-1R). CELLS EXHIBIT ANTI-TUMORAL ACTIVITY IN PATIENTS WITH MULTIPLE MYELOMA
ORVACABTAGENE AUTOLEUCEL [INN]
ORVACABTAGENE AUTOLEUCEL [USAN]
ORVACABTAGENE AUTOLEUCEL [WHO-DD]

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.

ORVACABTAGENE AUTOLEUCEL

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