ROMUCABTAGENE AUTOLEUCEL
UNII S2H6M754GZ

Substance Identification & Data

This profile provides standardized clinical and technical data for Romucabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) S2H6M754GZ.

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
S2H6M754GZ
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
ROMUCABTAGENE AUTOLEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
INN ID
13809
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
Romucabtagene 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 Romucabtagene 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

Romucabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a non-replicating gamma-retroviral vector derived from myeloproliferative sarcoma virus and murine embryonic stem cell virus, encoding a chimeric antigen receptor (CAR) targeting the B-cell maturation antigen (BCMA; TNFRSF17, CD269) and a truncated human epidermal growth factor receptor (tEGFR) separated from the CAR by a P2A self-cleaving peptide sequence derived from porcine teschovirus type 1. The expressed transgene comprises a CD8α signal peptide, an anti-BCMA single chain variable fragment (scFv) derived from clone C11D5.3, a CD8α hinge, a CD8α transmembrane region, a 4-1BB co-stimulatory domain and a CD3ζ signalling domain. The tEGFR is preceded by a granulocyte macrophage colony-stimulating factor receptor (GM-CSFR) signal peptide. The construct is flanked by 5' and 3' long terminal repeats (LTRs), which control transcription and polyadenylation respectively, and contains a psi (Ψ) packaging signal. The vector is pseudotyped with the gibbon ape leukaemia virus (GALV) envelope (Env) glycoprotein. The peripheral blood mononuclear cells (PBMC) are selected and activated with anti-CD3 / anti-CD28 agonistic antibodies in growth media containing interleukin 2 (IL-2). The cells are then transduced with the retroviral viral vector and further expanded in growth medium containing IL-2. The T lymphocytes (≥95%) are positive for the transgene (≥15% CAR positive), and express CD107a (≥20%) after co-incubation with BCMA+ target cells. In addition, the cells demonstrate cytotoxicity against BCMA expressing cells and secrete interferon gamma (IFN-γ) and IL-2
romucabtagene autoleucel [INN]

External Clinical & Regulatory Resources

NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record