VARNIMCABTAGENE AUTOLEUCEL
UNII PA5M8REK2P

Substance Identification & Data

This profile provides standardized clinical and technical data for Varnimcabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) PA5M8REK2P.

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

PA5M8REK2P

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

VARNIMCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C179725

National Cancer Institute reference terminology for clinical and research data.

INN ID

12208

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Varnimcabtagene 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 Varnimcabtagene 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

Varnimcabtagene Autoleucel

Common Names & Synonyms

Varnimcabtagene autoleucel [WHO-DD]

autologous T lymphocytes obtained from peripheral blood lymphocytes by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor targeting CD19. The expressed transgene comprises a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) derived from clone A3B1, a CD8α hinge and transmembrane region, and a 4-1BB (CD137) and CD3ζ (CD247) signalling domain and is 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 Rev response element (RRE), a central polypurine tract (cPPT) sequence, a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and a remnant of a deleted nef gene (The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the vector. The cells are then expanded in media supplemented with human AB serum from healthy male donors, interleukin (IL) 7 and IL-15. The cell suspension consists of T lymphocytes (>70%), with greater than 20% of the T lymphocytes expressing the CAR transgene, and cytotoxic potency is measured against a CD19+ leukemia cell line)

varnimcabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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