POMLUCABTAGENE AUTOLEUCEL
UNII 22TCU7HE9E

Substance Identification & Data

This profile provides standardized clinical and technical data for Pomlucabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 22TCU7HE9E.

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

22TCU7HE9E

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

POMLUCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C203125

National Cancer Institute reference terminology for clinical and research data.

INN ID

12254

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Pomlucabtagene 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 Pomlucabtagene 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

Pomlucabtagene autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating murine stem cell virus (MSCV) vector, encoding a chimeric antigen receptor (CAR) targeting human ganglioside GM2. The expressed CAR transgene comprises a leader sequence derived from a human immunoglobulin heavy chain, a human GM2-specific single-chain variable fragment (scFv), a human CD8 transmembrane domain, CD28, 4-1BB and CD3ζ intracellular signal motif. The vector genome also contains transgenes encoding human interleukin-7 (IL-7), human C-C motif chemokine 19 (CCL19) and herpes simplex virus-derived thymidine kinase transgene (HSV-tk), with each transgene separated by sequences encoding a foot and mouth disease 2A self-cleaving peptide. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and expression is under the control of the 5' LTR promoter. The leukapheresis material is enriched for CD3 T lymphocytes by positive immunoselection, and cultured in bags coated with anti-CD3 and recombinant human fibronectin, in media containing interleukin 2 (IL-2). The activated cells are transduced with the vector before further culture expansion in growth media containing IL-2. The cell suspension consists of T lymphocytes (>80%), with greater than 5% of the T lymphocytes expressing the anti-GM2 transgene. The T lymphocytes secrete interferon gamma (IFN-γ) and also transgene-derived IL-7 and CCL19 following co-culture with GM2-expressing cells

pomlucabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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