OLMOCABTAGENE AUTOLEUCEL
UNII RSC598M6W5

Substance Identification & Data

This profile provides standardized clinical and technical data for Olmocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) RSC598M6W5.

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

RSC598M6W5

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

OLMOCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C215290

National Cancer Institute reference terminology for clinical and research data.

INN ID

13540

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Olmocabtagene 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 Olmocabtagene 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

Olmocabtagene Autoleucel

Common Names & Synonyms

autologous CD4+/CD8+ enriched T lymphocytes obtained by leukapheresis, transduced with a self-inactivating, nonreplicating gamma Moloney murine leukemia virus (MMLV) vector encoding a chimeric antigen receptor (CAR) targeting claudin 6 (CLDN6), composed of a human IgG heavy chain signal peptide, a single chain variable fragment (scFv; IMAB206-C46S), a CD8 hinge and transmembrane domain, and a 4-1BB co-stimulatory and CD3ζ intracellular signalling domain, under control of the elongation factor 1 alpha short (EFS) promoter. The vector also contains an MMLV psiregion, an enlarged MMLV psi+ packaging region, a Kozak sequence, and a truncated version of the posttranscriptional regulatory element of the Woodchuck hepatitis virus (WPRE); flanked by 5' and 3' MMLV wildtype long terminal repeats (LTRs). The vector is pseudotyped with gibbon ape leukemia virus (GALV) envelope protein. The leukapheresis material is enriched for CD4+/CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the retroviral vector. The cells are then expanded in media with interleukin 15 (IL-15) and interleukin 7 (IL-7). The T lymphocytes (≥80%; with ≤20% CD3- cells) are positive for the transgene (≥10% CAR positive) and secrete interferon gamma in response to CLDN6 expressing target cells

olmocabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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