NELDALEUCEL
UNII 78SU4N7MVG

Substance Identification & Data

This profile provides standardized clinical and technical data for Neldaleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 78SU4N7MVG.

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

78SU4N7MVG

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

NELDALEUCEL

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

NCI Thesaurus

C200467

National Cancer Institute reference terminology for clinical and research data.

INN ID

13215

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

LM-134

Identifier assigned by the United States Adopted Names Council.

Substance Type

structurallyDiverse

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 Neldaleucel. 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

NELDALEUCEL

Common Names & Synonyms

AUTOLOGOUS MULTI (6) TUMOR-ASSOCIATED ANTIGEN (TAA)-SPECIFIC T CELL PRODUCT THAT IS SPECIFICALLY DIRECTED AGAINST THE FOLLOWING SIX TAAS: PREFERENTIALLY EXPRESSED ANTIGEN IN MELANOMA (PRAME), WILMS TUMOR 1 (WT1), NEW YORK ESOPHAGEAL 1 (NY-ESO-1), SYNOVIAL SARCOMA X BREAKPOINT 2 (SSX2), MELANOMA-ASSOCIATED ANTIGEN A4 (MAGE-A4) AND SURVIVIN

MT-601 IS AN AUTOLOGOUS MULTI-TUMOR ASSOCIATED ANTIGEN (TAA)-SPECIFIC T CELL IMMUNOTHERAPY PRODUCT THAT DEPENDING ON THE PATIENT'S ENDOGENOUS PRECURSORS RECOGNIZES CANCER CELLS EXPRESSING AT LEAST ONE OF THE 6 TAAS VIA NATIVE T CELL RECEPTORS (TCRS), WHICH INTERACT WITH CLASS I AND II MAJOR HISTOCOMPATIBILITY COMPLEX (MHC ALSO KNOWN AS HLA (HUMAN LEUKOCYTE ANTIGEN)) PRESENTING THE ANTIGENIC PEPTIDES. THE INTERACTION BETWEEN TCRS AND THE TUMOR ANTIGEN EPITOPES LEADS TO T CELL ACTIVATION, PROLIFERATION, AND ACQUISITION OF EFFECTOR FUNCTIONS (E.G., SECRETION OF INFLAMMATORY CYTOKINES AND/OR CHEMOKINES AND CYTOTOXICITY). THIS SEQUENCE OF EVENTS LEADS TO KILLING OF TUMOR CELLS EXPRESSING THESE ANTIGENS AS WELL AS THE ACTIVATION OF OTHER IMMUNE CELLS IN THE TUMOR MICROENVIRONMENT

NELDALEUCEL [USAN]

Technical Codes

MT-601

External Clinical & Regulatory Resources

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