DICOCABTAGENE AUTOLEUCEL
UNII Y8HFK62WVL

Substance Identification & Data

This profile provides standardized clinical and technical data for Dicocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Y8HFK62WVL.

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

Y8HFK62WVL

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DICOCABTAGENE AUTOLEUCEL

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

INN ID

13810

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Dicocabtagene 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 Dicocabtagene 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

Dicocabtagene Autoleucel

Common Names & Synonyms

Dicocabtagene autoleucel [INN]

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a CD19-specific chimeric antigen receptor (CAR) comprising a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) (derived from the mouse hybridoma FMC63), a CD8α hinge and transmembrane domain, an intracellular 4-1BB (CD137) co-stimulatory domain and a CD3ζ signalling domain and is under control of the elongation factor 1 alpha (EF-1α) core promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a human immunodeficiency virus 1 (HIV-1) ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) and central termination sequence (CTS) and a mutated Woodchuck hepatitis virus post transcriptional regulatory element (WPRE mut6). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The peripheral blood mononuclear cells (PBMC) are selected and activated with anti-CD3/anti-CD28 agonistic antibodies in growth media containing interleukin 2 (IL-2). The cells are then transduced with the lentiviral vector and expanded in growth media containing IL-2. The T lymphocytes (≥90%) are positive for the transgene (≥5% CAR+), and after co-incubation with CD19-expressing target cells demonstrate cytotoxicity and secrete interferon gamma (IFN-γ) and IL-2

External Clinical & Regulatory Resources

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