SITOCABNAGENE LOXIVELEUCEL
UNII HB2DF85W83

Substance Identification & Data

This profile provides standardized clinical and technical data for Sitocabnagene Loxiveleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) HB2DF85W83.

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

HB2DF85W83

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SITOCABNAGENE LOXIVELEUCEL

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

NCI Thesaurus

C203060

National Cancer Institute reference terminology for clinical and research data.

INN ID

11900

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

LM-222

Identifier assigned by the United States Adopted Names Council.

Substance Type

Sitocabnagene Loxiveleucel

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 Sitocabnagene Loxiveleucel. 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

Sitocabnagene Loxiveleucel

Common Names & Synonyms

SITOCABTAGENE LOXIVELEUCEL [USAN]

allogeneic natural killer (NK) cells derived from umbilical cord blood, transduced with a Moloney murine leukaemia virus (MMLV)-based retroviral vector encoding inducible caspase-9 comprising human caspase-9 fused to a human FK506 binding protein variant (FKBP-F36V), a chimeric antigen receptor (CAR) targeting CD19 fused to CD28 and CD3 zeta signaling domains, and secretable human interleukin 15 (IL-15), linked together by T2A and E2A self-cleaving peptide sequences, respectively, under the control of the 5' long terminal repeat (LTR) MMLV promoter; the construct is flanked by 5' and 3' LTRs and contains an MMLV ψ packaging signal and partial pol gene. The vector is pseudotyped with the envelope glycoprotein of gibbon ape leukaemia virus (GaLV). The cord blood mononuclear cells are treated with antibody-coated magnetic beads against CD19, CD3 and CD14 to remove B cells, T cells, and monocytes. The purified NK cells are then activated using an irradiated antigen presenting cell line (APC) in the presence of growth medium containing IL-2. Further depletion of residual CD3+ T cell may be performed using antibody-coated magnetic beads. The substance contains >80% NK cells (CD45+CD3-CD56+), of which with >21% are CAR positive, and secrete IL-15.

sitocabnagene loxiveleucel [INN]

Technical Codes

TAK-007

External Clinical & Regulatory Resources

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