RONDECABTAGENE AUTOLEUCEL
UNII YRT2H8MH4G

Substance Identification & Data

This profile provides standardized clinical and technical data for Rondecabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) YRT2H8MH4G.

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

YRT2H8MH4G

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

RONDECABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C199659

National Cancer Institute reference terminology for clinical and research data.

INN ID

13527

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Rondecabtagene 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 Rondecabtagene 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

Rondecabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained by leukapheresis enriched for the cell surface marker CD62L (also known as L-selectin) transduced with a self-inactivating non-replicating lentiviral vector encoding a tandem chimeric antigen receptor (CAR) targeting both CD20and CD19 [comprising a single chain variable fragment (scFvs) derived from the antibody clone Leu16 fused via flexible linkers to a scFvs derived from clone FMC63]. The transgene has a murine immunoglobulin kappa (mIgK) leader sequence and also comprises an IgG4 hinge, a CD28 transmembrane, and the intracellular 4-1BB costimulatory and CD3ζ signaling domains and is under control of the elongation factor 1 alpha (EF-1α) promoter and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) modified to eliminate the X-protein open reading frame. The vector genome also contains a human immunodeficiency virus (HIV) packaging signal, a Rev response element (RRE), central polypurine tract and central termination sequence (cPPT/CTS) and is flanked by 5' and 3' long terminal repeats (LTRs). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD62L expressing T lymphocytes by positive immunoselection and cultured in media containing interleukin 2 (IL-2) and interleukin 15 (IL-15). The lymphocytes are activated by CD3 and CD28 agonists and transduced with the lentiviral vector followed by culture in media containing IL-2 and IL-15. The T lymphocytes (≥80%) are predominantly composed of naïve and central memory rich T lymphocyte subsets as measured by expression of CD62L and CD45RA surface markers, and positive for the transgene (≥10% CAR positive) with few (<5%) CD19 expressing B lymphocytes.

rondecabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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