FIRICABTAGENE AUTOLEUCEL
UNII 4BEJ6K4DQ9

Substance Identification & Data

This profile provides standardized clinical and technical data for Firicabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 4BEJ6K4DQ9.

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

4BEJ6K4DQ9

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

FIRICABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C203126

National Cancer Institute reference terminology for clinical and research data.

INN ID

12829

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

MN-211

Identifier assigned by the United States Adopted Names Council.

Substance Type

Firicabtagene Autoleucel

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 Firicabtagene 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

Firicabtagene Autoleucel

Common Names & Synonyms

Autologous T lymphocytes obtained from peripheral blood by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human CD22. The expressed transgene comprises the granulocyte-macrophage colony-stimulating factor receptor subunit alpha (GMCSFR-alpha) signal sequence, an anti-CD22 single chain variable fragment (scFv), a CD8α hinge and transmembrane domain, a 4-1BB costimulatory domain and CD3ζ primary stimulatory domain, under control of the human elongation factor 1 alpha (EF-1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a truncated gag, a Rev response element (RRE), a central polypurine tract (cPPT) sequence 5' to the transgene, and a partial nef/polypurine tract (PPT) sequence 3' to the transgene. The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media containing human AB serum, interleukin 7 (IL-7) and 15 (IL-15). The T lymphocytes (≥70 % CD3+) are positive for the transgene (≥10% CAR positive), demonstrate cytotoxicity against CD22 expressing cells, and secrete interferon gamma in response to CD22 expressing tumour cell lines

FIRICABTAGENE AUTOLEUCEL [USAN]

Firicabtagene autoleucel [WHO-DD]

firicabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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