LUMOCABTAGENE GELEUCEL
UNII 2JR5UJR7B3

Substance Identification & Data

This profile provides standardized clinical and technical data for Lumocabtagene Geleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 2JR5UJR7B3.

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

2JR5UJR7B3

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

LUMOCABTAGENE GELEUCEL

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

NCI Thesaurus

C223290

National Cancer Institute reference terminology for clinical and research data.

INN ID

13652

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Lumocabtagene Geleucel

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 Lumocabtagene Geleucel. 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

Lumocabtagene Geleucel

Common Names & Synonyms

allogeneic CD4+/CD8+ T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis of healthy donors, transduced with a lentiviral vector to overexpress CD47 and a CD22-directed chimeric antigen receptor (CAR). The cells have also been gene-edited using clustered regularly interspaced short palindromic repeats (CRISPR)-Cas12b nuclease introduced as mRNA in combination with single guide RNAs (sgRNAs) to disrupt the T cell receptor alpha constant (TRAC), beta-2 microglobulin (B2M), and class II major histocompatibility complex transactivator (CIITA) gene loci. The lentivirus vector genome is flanked by 5' and 3' long terminal repeats (LTRs) and contains a human immunodeficiency virus (HIV) packaging signal, HIV gag, HIV envelope, Rev response element (RRE), and central polypurine tract/central termination sequences as well as a mutant Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The CD47-CD22 transgene comprises a codon optimised CD47 coding region, a furin cleavage sequence, a Thosea asigna virus 2A (T2A) ribosomal skip sequence, a granulocyte-macrophage colony-stimulating factor receptor (GMCSFR) signal peptide, an anti-CD22 single chain variable fragment (based uponclone m971), fused to a CD8α hinge, CD8α transmembrane, 4-1BB co-stimulatory and CD3ζ signalling domain, and is under control of the human elongation factor 1α promoter (EF-1α). The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and subject to gene editing. The cells are then expanded in media supplemented with serum replacement and interleukin 2 (IL-2). The cell suspension consists of T lymphocytes (CD4+ and CD8+; ≥90%) with ≥25% of the T lymphocytes expressing the CAR transgene, and with ≥70% B2M disrupted, and ≥70% CIITA disrupted cells.

lumocabtagene geleucel [INN]

External Clinical & Regulatory Resources

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