LASMECABTAGENE TIMGEDLEUCEL
UNII 5GP3N2YX96

Substance Identification & Data

This profile provides standardized clinical and technical data for Lasmecabtagene Timgedleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 5GP3N2YX96.

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
5GP3N2YX96
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
LASMECABTAGENE TIMGEDLEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
National Cancer Institute reference terminology for clinical and research data.
INN ID
13170
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
NO-222
Identifier assigned by the United States Adopted Names Council.
Substance Type
Lasmecabtagene Timgedleucel
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 Lasmecabtagene Timgedleucel. 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

Lasmecabtagene Timgedleucel

Common Names & Synonyms

LASMECABTAGENE TIMGEDLEUCEL [USAN]
UCART22 is defined as allogeneic, non-alloreactive T-cells, transduced with a selfinactivating (SIN) recombinant lentiviral vector to express an anti-CD22 CAR and RQR8, and genetically edited with TALEN® (Transcription Activator Like Effector Nucleases) to disrupt the CD52 and the T cell receptor alpha constant (TRAC) genes
allogeneic T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis of healthy donors, transduced with a selfinactivating, non-replicating lentiviral vector encoding a depletion ligand and a chimeric antigen receptor (CAR) targeting CD22. The cells are also genetically modified using transcription activator-like (TAL) effector nucleases, which are transiently delivered into the cell as mRNAs to disrupt the T cell receptor alpha constant (TRAC) and CD52 genes. The expressed transgene comprises the RQR8 depletion ligand, a T2A ribosomal skip motif and an anti-CD22 CAR, under control of the human elongation factor-1 alpha (EF-1α) promoter. The RQR8 ligand is a 136 amino acid artificial cell surface protein that combines the antibody-binding epitopes from human CD20 (R) and human CD34 (Q) in the order of R, Q and R, followed by a CD8α hinge and transmembrane domain. The CAR comprises an anti-CD22 single chain variable fragment (scFv), a CD8α hinge and transmembrane domain, and 4-1BB (CD137) and CD3ζ (CD247) intracellular costimulatory domains. 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 and a mutated Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. Proposed INN: List 131 WHO Drug Information, Vol. 38, No. 2, 2024 362 The leukapheresis material is activated by CD3 and CD28 agonists and transduced with the vector. Residual TCRαβ+ lymphocytes are removed by magnetic depletion, then cultured in media containing interleukin 2 (IL-2). The suspension consists primarily of T lymphocytes with >30% CAR+ and ≤3.0% TCRαβ+ T lymphocytes. The cells are cytotoxic and secrete pro-inflammatory cytokines in response to CD22-expressing cells.
lasmecabtagene timgedleucel [INN]

Technical Codes

UCART-22
UCART22