RUNITRESGENE LEUCEL
UNII C6LF4ED2YD

Substance Identification & Data

This profile provides standardized clinical and technical data for Runitresgene Leucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) C6LF4ED2YD.

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

C6LF4ED2YD

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

RUNITRESGENE LEUCEL

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

NCI Thesaurus

C215764

National Cancer Institute reference terminology for clinical and research data.

INN ID

13441

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Runitresgene Leucel

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 Runitresgene Leucel. 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

Runitresgene Leucel

Common Names & Synonyms

allogeneic T lymphocytes derived from peripheral blood mononuclear cells (PBMCs) of a haploidentical hematopoietic cell transplantation (HCT) donor that is negative for the HA-2 genotype and/or negative for HLA A*02, engineered by transposon/transposase-mediated gene delivery to express a T cell receptor (TCR) that is specific for a 9-amino acid peptide (YIGEVLVSV) termed HA-2, derived from myosin 1G (MYO1G) and presented on HLA-A*02:01. The TCR comprises α and β subunits separated by a P2A self-cleaving peptide. The transgene also encodes a codon-optimised CD8 co-receptor consisting of α and β chains separated by a P2A self-cleaving peptide, with the CD8 co-receptor separated from the TCR by an additional P2A self-cleaving peptide. Each P2A sequence is preceded by a furin cleavage site. A 16 amino acid epitope encoding a portion of human CD34 is incorporated into the Nterminus of the CD8α chain. The transgene is under the control of a murine stem cell virus (MSCV) promoter, a Woodchuck hepatitis virus post-transcriptional response element and a simian virus 40 (SV40) polyadenylation (polyA) signal. The transposase (Armyworm transposase) is introduced in form of an mRNA that comprises an anti-reverse cap analogue, a Xenopus globin 5' untranslated region (UTR), a Kozak sequence, the transposase open reading frame, and a Xenopus globin 3' UTR. The transgene is introduced via a nanoplasmid DNA and contains inverted terminal repeats (ITRs). The leukapheresis material is electroporated with mRNA transposase as well as the nanoplasmid transposon followed by activation with CD2, CD3 and CD28 agonists. The cells are grown in serum free media supplemented with interleukin 2 (IL-2), interleukin 7 (IL-7) and interleukin 15 (IL-15). The T lymphocytes (≥95%) are positive for the transgene (≥80% TCR+), and release interferon -gamma (IFN-γ) in response

runitresgene leucel [INN]

External Clinical & Regulatory Resources

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