ZUGOCABTAGENE GELEUCEL
UNII K5R7KG9L3K

Substance Identification & Data

This profile provides standardized clinical and technical data for Zugocabtagene Geleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) K5R7KG9L3K.

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

K5R7KG9L3K

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ZUGOCABTAGENE GELEUCEL

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

NCI Thesaurus

C224808

National Cancer Institute reference terminology for clinical and research data.

INN ID

13802

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Zugocabtagene 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 Zugocabtagene 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

Zugocabtagene Geleucel

Common Names & Synonyms

allogeneic T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis of healthy donors, electroporated with CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9)-guide RNA (gRNA) nucleoprotein complexes to knock out the T cell receptor alpha chain constant (TRAC), the beta 2 microglobulin (B2M) locus, the transforming growth factor beta receptor 2 (TGFBR2) locus and the Regnase-1 (ZC3H12A) locus. The cells are also transduced with a recombinant adeno-associated virus serotype 6 vector (rAAV6) to introduce an anti-CD19 chimeric antigen receptor (CAR) expression cassette at the TRAC locus by homology-directed repair. The integrated sequence comprises a 5' TRAC homology arm, the CAR expression cassette and a 3' TRAC homology arm. The CAR expression cassette comprises an elongation factor alpha (EF-1α) promoter, a granulocyte-macrophage colony-stimulating factor receptor subunit alpha (CSF2RA) signal peptide, the anti-CD19 single chain variable fragment (scFv; FMC63), CD8α transmembrane domain, CD28 co-stimulatory domain, CD3ζ signalling domain and is followed by a synthetic polyadenylation sequence. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection and activated in media containing CD3 and CD28 agonists prior to transduction with the vector and further cell expansion. Finally, the lymphocytes are cultured in media containing human AB serum, interleukin 2 (IL-2) and IL-7 for two days prior to removal of the residual TCRαβ+ lymphocytes by magnetic depletion. The suspension consists primarily of T lymphocytes (CD5+ ≥95%) which are >30% CAR+ (<0.15% TCR+ T lymphocytes), have on-target editing of ZC3H12A (≥80%) and TGFBR2 (≥80%) and are cytotoxic to CD19-expressing cells

zugocabtagene geleucel [INN]

External Clinical & Regulatory Resources

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