U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Approval Year

Substance Class Structurally Diverse
Created
by admin
on Wed Apr 02 20:56:24 GMT 2025
Edited
by admin
on Wed Apr 02 20:56:24 GMT 2025
Source Materials Class ORGANISM
Source Materials Type ALLOGENIC HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part BLOOD
Fraction Material Type CELL
Fraction Name CD4+ AND CD8+ enriched T cells
Record UNII
Z75Y8V4FFA
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
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
Preferred Name English
Soficabtagene Geleucel
INN  
Official Name English
soficabtagene geleucel [INN]
Common Name English
Code System Code Type Description
FDA UNII
Z75Y8V4FFA
Created by admin on Wed Apr 02 20:56:24 GMT 2025 , Edited by admin on Wed Apr 02 20:56:24 GMT 2025
PRIMARY
INN
13448
Created by admin on Wed Apr 02 20:56:24 GMT 2025 , Edited by admin on Wed Apr 02 20:56:24 GMT 2025
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE ACTIVATOR BIOLOGICAL T CELL TRANSACT, HUMAN YG578HEY4V
ELECTROPORATION GENE EDITING BIOLOGICAL Soficabtagene geleucel single gRNA targeting TRAC locus 93A4Y2S6E2
ELECTROPORATION GENE EDITING GENE MODIFICATION Soficabtagene geleucel single gRNA targeting CD7 locus ENS57C5JUZ
CULTURE EXPANSION BIOLOGICAL ALDESLEUKIN M89N0Q7EQR
CULTURE EXPANSION BIOLOGICAL RECOMBINANT HUMAN INTERLEUKIN-15 VL2UPV1APW
ELECTROPORATION GENE EDITING GENE MODIFICATION Soficabtagene geleucel expressed Truncated CD34 (trCD34) L5W7FYJ593
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Soficabtagene geleucel lentiviral vector ZY2QR8ZJZ5

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Soficabtagene geleucel expressed chimeric antigen receptor (CAR) targeting CD7 ZXZ34ABJ6C
INSERTED GENE EXPRESSION VECTOR Soficabtagene geleucel transgene insert encoding anti-CD7 CAR KBJ527FP3Z
PROTEIN NOT EXPRESSED (GENE DISRUPTION) HUMAN T-CELL ALPHA/BETA RECEPTOR 8OO8E2BVQ4
PROTEIN NOT EXPRESSED (GENE DISRUPTION) T-CELL ANTIGEN CD7 TL0IX769BQ