CESNICABTAGENE AUTOLEUCEL
UNII DCY3M5W6TC

Substance Identification & Data

This profile provides standardized clinical and technical data for Cesnicabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) DCY3M5W6TC.

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

DCY3M5W6TC

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

CESNICABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C176769

National Cancer Institute reference terminology for clinical and research data.

INN ID

13034

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Cesnicabtagene 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 Cesnicabtagene 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

Cesnicabtagene Autoleucel

Common Names & Synonyms

Cesnicabtagene autoleucel [WHO-DD]

autologous T lymphocytes obtained from peripheral blood mononuclear cells (PBMC) by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting the B-cell maturation antigen (BCMA). The expressed transgene comprises an IgGκ chain V-III leader sequence, a humanized anti-BCMA single chain variable fragment (scFv, clone J22.9), a CD8α hinge and transmembrane domain, and a 4-1BB co-stimulatory domain and CD3ζ signalling 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 Rev response element (RRE), a central polypurine tract (cPPT) sequence and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with the vesicular stomatitis virus (VSV) G envelope protein. The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 7 (IL-7) and interleukin 5 (IL-5). The cells are then transduced with the lentiviral vector and expanded in growth media containing interleukin 7 (IL-7) and interleukin 5 (IL-5). The cell suspension consists of T lymphocytes (>70%), with greater than 20% of the T lymphocytes expressing the CAR-BCMA transgene. The transduced T lymphocytes demonstrate cytotoxicity against BCMA-expressing cells

cesnicabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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