SOFICABTAGENE GELEUCEL
UNII Z75Y8V4FFA

Substance Identification & Data

This profile provides standardized clinical and technical data for Soficabtagene Geleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Z75Y8V4FFA.

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

Z75Y8V4FFA

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SOFICABTAGENE GELEUCEL

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

NCI Thesaurus

C215281

National Cancer Institute reference terminology for clinical and research data.

INN ID

13448

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Soficabtagene Geleucel

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 Soficabtagene Geleucel. 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

Soficabtagene Geleucel

Common Names & Synonyms

allogeneic CD4+ and CD8+ T lymphocytes derived from leukapheresis material of healthy donors, genetically modified using CRISPR/Cas9 gene editing to knockout the expression of endogenous CD7 and TRAC using inactivating, non-replicating lentivirus vector encoding an anti-CD7 chimeric antigen receptor (CAR) comprising a CD8 leader sequence, anti-CD7 single-chain variable fragment (scFv)(clone TH69), CD8 hinge, CD28 transmembrane domain, 4-1BB costimulatory domain and CD3ζ intracellular signalling domain, under control of the elongation factor 1 alpha (EF-1α) promoter. The transgene also encodes a truncated human CD34 extracellular domain separated from the CAR by a 2A peptide derived from porcine teschovirus-1. The CRISPR/Cas9 and gRNAs are introduced as a ribonucleoprotein (RNP) complex by electroporation. The lentivirus vector is flanked by 5' and 3' LTRs and also contains a viral packaging sequence ψ, partial gag, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS) and a synthetic identification (ID) sequence. The vector is pseudotyped with VSV G envelope glycoprotein. The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 7 (IL-7) and interleukin 15 (IL-15). The cells are gene-edited and then transduced with the lentiviral vector and expanded in growth media containing human AB serum, IL-7, and IL-15. The cell suspension consists of T lymphocytes (≥98.0% CD45+, ≤1.0% CD7+, ≤8.0% CD3+) with greater than 30% of the T lymphocytes expressing the CAR transgene and >70% (CD7) and >85% (TRAC) on-target gene editing. The transduced T lymphocytes demonstrate cytotoxicity against CD7+ Tlymphoblastic target cells

soficabtagene geleucel [INN]

External Clinical & Regulatory Resources

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