NESPECABTAGENE AUTOLEUCEL
UNII LN7HYS3NX9

Substance Identification & Data

This profile provides standardized clinical and technical data for Nespecabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) LN7HYS3NX9.

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

LN7HYS3NX9

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

NESPECABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C211707

National Cancer Institute reference terminology for clinical and research data.

INN ID

13126

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Nespecabtagene 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 Nespecabtagene 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.

Common Names & Synonyms

Nespecabtagene Autoleucel

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 CD19. The expressed transgene comprises a CD8α signal peptide, a humanized anti-CD19 single chain variable fragment (scFv) derived from scFv clone 1218, a CD8α hinge and transmembrane region, and a 4-1BB co-stimulatory domain and CD3ζ signaling domain, under control of the elongation factor 1 alpha (EF1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs), and also contains a ψ packaging signal, a part of the human immunodeficiency virus (HIV) gag and env genes, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS), a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE), a qPCR ID tag, and part of the HIV nef gene. 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 supplemented with serum replacement and interleukin 2 (IL-2). The cell suspension consists of T lymphocytes (≥94%) with greater than 25% of the T lymphocytes expressing the CAR transgene. Cells exhibit antitumoral activity in patients with CD19-expressing B cell malignancies

nespecabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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