FENCABTAGENE AUTOLEUCEL
UNII WD9M7WQ9SY

Substance Identification & Data

This profile provides standardized clinical and technical data for Fencabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) WD9M7WQ9SY.

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

WD9M7WQ9SY

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

FENCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C178298

National Cancer Institute reference terminology for clinical and research data.

INN ID

12821

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Fencabtagene 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 Fencabtagene 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

Fencabtagene Autoleucel

Common Names & Synonyms

Autologous anti-HER2 T-cell antigen coupler-expressing T cells TAC01-HER2

TAC-engineered T cells TAC01-HER2

autologous CD4/CD8 enriched T lymphocytes obtained from peripheral blood by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor targeting human receptor tyrosine-protein kinase erbB-2 (also known as epidermal growth factor receptor 2 (HER2)). The expressed transgene comprises a human immunoglobulin G (IgG) leader sequence, an extracellular HER2-binding domain provided by a designed ankyrin repeat protein, a human c-Myc tag sequence, an anti-T cell receptor (TCR)/CD3ε binding domain provided by the humanized UCHT1 single-chain antibody fragment (scFv), and a CD4 co-receptor membrane anchoring and intracellular domain, under the control of the murine stem cell virus (MSCV) promoter and 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, a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and a synthetic ID tag sequence. The vector is pseudotyped by vesicular stomatitis virus (VSV) glycoprotein G (The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection. The cells are then activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are further culture expanded in growth media with serum replacement containing interleukin 2 (IL-2) and 7 (IL-7). The cell suspension consists of T lymphocytes (>96% CD3+) with greater than 10% (average 45%) of the T lymphocytes expressing the transgene)

fencabtagene autoleucel [INN]

Technical Codes

TACTIC-2

External Clinical & Regulatory Resources

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