PERSICABTAGENE LEMGEDLEUCEL
UNII 9C6AT9DSU2
Substance Identification & Data
This profile provides standardized clinical and technical data for Persicabtagene Lemgedleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 9C6AT9DSU2.
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.
9C6AT9DSU2
N/A
N/A
Detailed Substance Profile
Preferred Name
PERSICABTAGENE LEMGEDLEUCEL
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
13136
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
NO-192
Identifier assigned by the United States Adopted Names Council.
Substance Type
Persicabtagene Lemgedleucel
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 Persicabtagene Lemgedleucel. 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
Persicabtagene Lemgedleucel
Common Names & Synonyms
A hypoimmune, genetically modified, allogeneic CAR T cell therapy targeting CD19. Healthy donor T cells are transduced with a lentiviral vector to incorporate gene sequences to overexpress CD47 and express a CD19-directed CAR. The donor T cells are also gene-edited with CRISPR/Cas12b to disrupt the TRAC, B2M, and CIITA genes
PERSICABTAGENE LEMGEDLEUCEL [USAN]
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 CD19-directed chimeric antigen receptor (CAR). The cells have also been gene-edited using CRISPR/Cas12b (clustered regularly interspaced short palindromic repeats/ CRISPRassociated protein 12b) The cells have also been gene-edited using CRISPR/Cas12b (clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 12b) 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, and a mutant Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The CD47-CD19 transgene comprises a codon optimised CD47 coding region, a furin cleavage sequence, a Thosea asigna virus 2A (T2A) ribosomal skip sequence, a CD8α signal peptide, and an anti-CD19 single chain variable fragment (clone FMC63), fused to a CD8α hinge, CD8α transmembrane, 4-1BB co-stimulatory and CD3ζ signaling domain and is under control of the human elongation factor-1 alpha 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 (≥90%) with greater than 35% of the T lymphocytes expressing the CAR transgene, and with ≥70% B2M disrupted, and ≥70% CIITA disrupted cells.
persicabtagene lemgedleucel [INN]
Technical Codes
SC-291
SC291
