ITEZOCABTAGENE AUTOLEUCEL
UNII 1T1JX1GA68

Substance Identification & Data

This profile provides standardized clinical and technical data for Itezocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 1T1JX1GA68.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

1T1JX1GA68

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ITEZOCABTAGENE AUTOLEUCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C203128

National Cancer Institute reference terminology for clinical and research data.

INN ID

11887

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

structurallyDiverse

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Itezocabtagene Autoleucel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

ITEZOCABTAGENE AUTOLEUCEL

Common Names & Synonyms

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]

External Clinical & Regulatory Resources

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