LECILIMOGENE AUTOTEMCEL
UNII J6D55C56ED

Substance Identification & Data

This profile provides standardized clinical and technical data for Lecilimogene Autotemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) J6D55C56ED.

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

J6D55C56ED

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

LECILIMOGENE AUTOTEMCEL

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

NCI Thesaurus

C188589

National Cancer Institute reference terminology for clinical and research data.

INN ID

12063

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

LECILIMOGENE AUTOTEMCEL

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 Lecilimogene Autotemcel. 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

LECILIMOGENE AUTOTEMCEL

Common Names & Synonyms

AUTOLOGOUS CD34+ CELLS OBTAINED BY APHERESIS FROM MOBILISED PERIPHERAL BLOOD OF PATIENTS WHO RECEIVED A PRIOR HEMATOPOIETIC STEM CELL TRANSPLANT, TRANSDUCED EX-VIVO WITH A SELF-INACTIVATING LENTIVIRAL VECTOR, ENCODING CODON-OPTIMIZED HUMAN INTERLEUKIN-2 RECEPTOR SUBUNIT GAMMA (IL2RG) ALSO KNOWN AS COMMON GAMMA CHAIN (.GAMMA.C), DRIVEN BY A SHORT VERSION OF THE EF1.ALPHA. PROMOTER AND THE VECTOR CONTAINS HUMAN IMMUNODEFICIENCY VIRUS (HIV) CENTRAL POLYPURINE TRACT SEQUENCES, THE HIV REV RESPONSE ELEMENT (RRE) AND IS FLANKED BY HIV LONG TERMINAL REPEATS. THE VECTOR ALSO CONTAINS A 400 BP INSULATOR FRAGMENT FROM THE CHICKEN .BETA.-GLOBIN LOCUS INSERTED INTO THE DELETED U3 REGION OF THE HIV LONG TERMINAL REPEAT FOLLOWED BY A POLYADENYLATION SEQUENCE DERIVED FROM THE RABBIT .BETA.-GLOBIN GENE. THE VECTOR IS PSEUDOTYPED WITH THE ENVELOPE GLYCOPROTEIN (G) OF VESICULAR STOMATITIS VIRUS (VSV) AND THE SUSPENSION IS ENRICHED FOR CD34+ CELLS USING MAGNETIC BEAD SEPARATION. THE CELLS ARE OVERNIGHT CULTURED IN MEDIA CONTAINING HUMAN SERUM ALBUMIN (1%), HUMAN STEM CELL FACTOR (SCF), HUMAN THROMBOPOIETIN PROTEIN (TPO), AND HUMAN FLT3 LIGAND (FLT3L) PRIOR TO VECTOR RANSDUCTION

lecilimogene autotemcel [INN]

External Clinical & Regulatory Resources

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