MACITEGTAGENE AUTOLEUCEL
UNII QQ55NF53RR

Substance Identification & Data

This profile provides standardized clinical and technical data for Macitegtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) QQ55NF53RR.

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

QQ55NF53RR

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

MACITEGTAGENE AUTOLEUCEL

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

NCI Thesaurus

C211716

National Cancer Institute reference terminology for clinical and research data.

INN ID

13281

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Macitegtagene 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 Macitegtagene 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

Macitegtagene Autoleucel

Common Names & Synonyms

autologous CD4/CD8 enriched T lymphocytes derived from peripheral blood mononuclear cells (PBMC) of patients by leukapheresis, transduced with a selfinactivating, non-replicating lentiviral vector encoding a a chimeric antigen receptor (CAR) targeting the intercellular adhesion molecule-1 (ICAM-1) fused to human somatostatin receptor type 2 (SSTR2), under control of the human elongation factor-1 alpha (EF-1α) promoter. A self-cleaving P2A peptide sequence separates the two transgenes. The CAR transgene comprises a CD8α signal peptide, a c-Myc tag, the I domain of the lymphocyte functionassociated antigen 1 (LFA-1, also known as integrin alpha-L, a natural ICAM-1 ligand) with an F292A mutation, a CD8α/CD28 hinge and transmembrane domain, a 4-1BB costimulatory domain and a CD3ζ signalling domain. The somatostatin receptor type 2 (SSTR2) is used to bind 68Ga-DOTA-TATE for visualization of the CAR T lymphocytes via positron emission tomography-computed tomography (PET-CT). The transgene construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a truncated gag, a Rev response element (RRE), a central polypurine tract (cPPT) sequence, a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and a qPCR synthetic ID tag sequence. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media supplemented with serum replacement and interleukin 2 (IL-2) and 7 (IL-7). The cell suspension consists of T lymphocytes (≥90%) with greater than 10% of the T lymphocytes expressing the transgene. The lymphocytes secrete interferon gamma (IFN-γ) and exhibit cytotoxic activity in response to culture with target tumor cells

macitegtagene autoleucel [INN]

External Clinical & Regulatory Resources

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