SUVUTRESGENE AUTOLEUCEL
UNII NU51FEX15J

Substance Identification & Data

This profile provides standardized clinical and technical data for Suvutresgene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) NU51FEX15J.

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

NU51FEX15J

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SUVUTRESGENE AUTOLEUCEL

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

NCI Thesaurus

C199017

National Cancer Institute reference terminology for clinical and research data.

INN ID

12538

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Suvutresgene 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 Suvutresgene 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

Suvutresgene Autoleucel

Common Names & Synonyms

Autologous T lymphocytes obtained from peripheral blood lymphocytes by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding an affinity-enhanced cancer testis antigen (NY-ESO-1 c259 ) specific T-cell receptor (TCR) and co-expressing a dominant-negative transforming growth factor beta (TGF-β) type II cell surface receptor (dnTGF-ßRII; truncated non-signalling TGF-βRII). The TCR is based on letetresgene autoleucel and specifically recognises a peptide (SLLMWITQC), which is shared by the cancer antigens NY-ESO-1 (CTAG1B) and LAGE-1a (CTAG2) presented on human leukocyte antigen HLA-A*02. The expressed transgene comprises dnTGF-ßRII joined by the foot-and-mouth disease virus ribosome skipping sequence (F2A) to the TCR α chain, joined by the porcine teschovirus-1 ribosome skipping sequence (P2A) to the TCR β chain and is under control of the elongation factor 1 alpha (EF1α) promoter. The construct is flanked by long terminal repeats (LTR) that have a deletion in the U3 part of the LTR, and also contains a ψ packaging signal, Rev response element (RRE), central polypurine tract (cPPT) and a central termination sequence (CTS). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. 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 initially in media supplemented with AB serum and interleukin 2 (IL-2), and then in media supplemented with only IL-2. The T lymphocytes (≥95%) are positive for the transgene (≥10% CAR positive), and are cytotoxic to T2 cells loaded with the target peptide

suvutresgene autoleucel [INN]

External Clinical & Regulatory Resources

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