MIVOCABTAGENE AUTOLEUCEL
UNII QTE27WBS5A

Substance Identification & Data

This profile provides standardized clinical and technical data for Mivocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) QTE27WBS5A.

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

QTE27WBS5A

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

MIVOCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C215283

National Cancer Institute reference terminology for clinical and research data.

INN ID

13488

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

OP-132

Identifier assigned by the United States Adopted Names Council.

Substance Type

Mivocabtagene Autoleucel

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 Mivocabtagene Autoleucel. 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

Mivocabtagene Autoleucel

Common Names & Synonyms

Human autologous T cells expressing a next-generation chimeric antigen receptor (CAR) construct comprising a fully human single-chain variable fragment (scFv) targeting CD19 fused to co-stimulatory domains

MIVOCABTAGENE AUTOLEUCEL [USAN]

autologous CD4+/CD8+ enriched T lymphocytes derived from leukapheresis material, transduced with a self-inactivating, non-replicating lentiviral vector encoding a CD19 targeting chimeric antigen receptor (CAR) comprising a CD8 alpha (CD8α) signal peptide, a single-chain variable fragment (scFv) derived from the human anti-CD19 monoclonal antibody clone 47G4, a CD8α hinge and transmembrane domain, a CD28 cytoplasmic co-stimulatory domain, and a CD3-zeta (CD3ζ) signaling domain, under control of the murine stem cell virus promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a Ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence /central termination sequence (CTS) and an optimised Woodchuck hepatitis virus posttranscriptional regulatory element. The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing human serum, interleukin 7 (IL-7) and interleukin 5 (IL-5). The cells are then transduced with the lentiviral vector and expanded in growth media containing interleukin 7 (IL-7) and interleukin 5 (IL-5). The cell suspension consists of T lymphocytes (>80%), with greater than 10% of the T lymphocytes expressing the CAR-CD19 transgene. The transduced T lymphocytes demonstrate cytotoxicity against CD19-expressing cells and secrete interferon gamma (IFN-γ) and interleukin 2 (IL-2)

mivocabtagene autoleucel [INN]

Technical Codes

KYV-101

External Clinical & Regulatory Resources

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