EMICABTAGENE LEUCEL
UNII N952MJE48Y

Substance Identification & Data

This profile provides standardized clinical and technical data for Emicabtagene Leucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) N952MJE48Y.

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

N952MJE48Y

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

EMICABTAGENE LEUCEL

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

NCI Thesaurus

C223281

National Cancer Institute reference terminology for clinical and research data.

INN ID

13721

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Emicabtagene Leucel

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 Emicabtagene Leucel. 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

Emicabtagene Leucel

Common Names & Synonyms

allogeneic CD4+ and CD8+ T lymphocytes derived from a patient's prior allogeneic hematopoietic stem cell transplantation donor, transduced with a self-inactivating, non-replicating (SIN) lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD33 (also known as sialic acid binding Ig-like lectin 3, Siglec-3) comprising a human CD8alpha leader sequence, a humanised anti-CD33 single chain variable fragment (scFv; derived from lintuzumab, clone huM195), a CD28 hinge region, CD28 transmembrane and co-stimulatory domain, and an intracellular signal transduction domain (CD3ζ), under control of the human elongation factor 1 alpha (EF-1α) promoter and Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a packaging signal, truncated gag, a Rev response element (RRE), an envelope glycoprotein 41 (gp41) peptide, a central polypurine tract/central termination sequence (cPPT/CTS) 5' to the transgene, and a partial nef/polypurine tract (PPT) sequence 3' to the transgene. The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The apheresis material collected from a patient's prior stem cell donor is enriched for CD4+/CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are expanded in media containing human AB serum and interleukin 2 (IL-2). The T lymphocytes (>94% CD3+) are positive for the transgene (>20% CAR positive), demonstrate cytotoxicity against CD33-expressing cells, and secrete interferon gamma in response to co-culture with CD33-expressing tumour cell lines

emicabtagene leucel [INN]

External Clinical & Regulatory Resources

Previous UNIIN94S395MFA

Next UNIIN954Y0TK3J