AMSOKIGENE AUTOLEUCEL
UNII SDW528DU9W

Substance Identification & Data

This profile provides standardized clinical and technical data for Amsokigene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) SDW528DU9W.

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

SDW528DU9W

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

AMSOKIGENE AUTOLEUCEL

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

NCI Thesaurus

C224711

National Cancer Institute reference terminology for clinical and research data.

INN ID

13634

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Amsokigene 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 Amsokigene 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

Amsokigene Autoleucel

Common Names & Synonyms

amsokigene autoleucel [INN]

autologous tumour-infiltrating lymphocytes (TILs) derived from patient tumour tissue such as melanoma or non-small cell lung cancer, transduced with a self-inactivating (SIN) gamma-retroviral vector encoding a fusion protein comprised of interleukin-15 (IL-15) fused to the C-terminal part of human CD80 that ensures membrane tethering of IL-15 via the CD80 transmembrane domain, separated by a GS linker from a human carbonic anhydrase 2 derived drug (acetazolamide) responsive domain (mbIL15-CA2DRD). The transgene is preceded by an immunoglobulin kappa light chain leader sequence and is under control of a retroviral MP71 promoter derived from a fragment of the myeloproliferative sarcoma virus U3 promoter, and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE; viral X-protein deleted). The vector also contains the Moloney murine leukemia virus (MMLV) psi packaging sequence, the MMLV psi+ region, and is flanked by 5' and 3' long terminal repeats (LTRs). The vector is pseudotyped with the Gibbon ape leukemia virus (GALV) envelope glycoprotein. The lymphocytes are mechanically isolated from resected tumour biopsies and culture expanded using a two-step protocol consisting of a cell expansion in medium supplemented with human AB serum, recombinant human interleukin 2 (rhIL-2), anti-CD3 antibody (muromonab-CD3) and anti-4-1BB antibody (urelumab). The cells are then activated with anti-CD3 prior to transduction with the gamma-retroviral vector. Following transduction, the cells are further cultured in the presence of irradiated feeder cells supplemented with human AB serum and acetazolamide. The final cell substance is primarily comprised of CD3+ T lymphocytes (≥80%) predominantly of CD8+ lineage, and ≥30% of cells express the IL-15 transgene. The CD8+ T lymphocytes generally consist of ≥90% effector memory T cells, <10% central memory and terminally differentiated effector memory T cells. The T-lymphocytes demonstrate interferon gamma (IFN-γ) release modulated by acetazolamide after CD3/CD28 bead stimulation

External Clinical & Regulatory Resources

Previous UNIISDW3N623LN

Next UNIISDW6SS1K6I