IMVUCABTAGENE GELEUCEL
UNII PXY6S56878

Substance Identification & Data

This profile provides standardized clinical and technical data for Imvucabtagene Geleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) PXY6S56878.

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

PXY6S56878

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

IMVUCABTAGENE GELEUCEL

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

NCI Thesaurus

C223286

National Cancer Institute reference terminology for clinical and research data.

INN ID

13757

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Imvucabtagene 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 Imvucabtagene 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.

Common Names & Synonyms

Imvucabtagene Geleucel

allogeneic T lymphocytes obtained from cryopreserved leukapheresis material of healthy donors, electroporated with CRISPR/Cas12a (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 12a) hybrid RNA-DNA (chRDNA) nucleoprotein complexes to knock out (i) the T cell receptor alpha chain constant (TRAC) and (ii) the beta-2 microglobulin (B2M) locus. The cells are also transduced with two recombinant adeno-associated virus serotype 6 (rAAV6) vectors to introduce (i) an anti-B-cell maturation antigen (BCMA, TNFRSF17, CD269) chimeric antigen receptor (CAR) flanked by TRAC homology regions that are inserted into the lymphocyte DNA by homology-directed repair, and (ii) a B2M-HLA-E peptide fusion protein flanked by beta-2 microglobulin (B2M) homology regions that are also inserted into the lymphocyte DNA by homology-directed repair. The anti-BCMA CAR expression cassette comprises in reverse orientation the synthetic MND promoter, Kozak sequence, CD8α signal sequence, anti-BCMA single chain variable fragment (scFv, clone PMC306), CD8 hinge region, CD8 transmembrane (TM) domain, 4-1BB co-stimulatory domain and CD3ζ signaling domain, followed by a bovine growth hormone (BGH) polyadenylation sequence. The B2M-HLA-E fusion protein expression cassette comprises a P2A skipping sequence, a B2M secretion signal, an HLA-G signal peptide sequence, the B2M peptide sequence followed by an HLA-E peptide sequence and a bovine growth hormone (BGH) polyadenylation sequence. The leukapheresis material is stimulated with anti-CD3 and anti-CD28 antibodies and cultured in the presence of interleukin 2 (IL-2) to enrich for T lymphocytes. The cells are subsequently electroporated with CRISPR/Cas12a chRDNA nucleoprotein complexes and transduced with the two AAV vectors followed by further cell expansion. Finally, residual TCRαβ+ lymphocytes are removed by magnetic depletion. The suspension consists primarily of T lymphocytes (CD4+/CD8+/CD3+ ≥70%) which are ≥32% CAR+, ≥20% B2M-HLA-E+ and are cytotoxic to BCMA expressing target cell

imvucabtagene geleucel [INN]

External Clinical & Regulatory Resources

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