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 20:23:07 GMT 2025
Edited
by admin
on Wed Apr 02 20:23:07 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part blood
Fraction Name cd4+ and cd8+ enriched t cells
Record UNII
XUA5T4H9TM
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous T lymphocytes obtained from peripheral blood by leukapheresis, transduced with two self-inactivating, nonreplicating lentiviral vectors encoding: (i) a chimeric antigen receptor (CAR) targeting human CD7: the expressed transgene comprises a gr
Preferred Name English
Osencabtagene Autoleucel
INN  
Official Name English
osencabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
SMS_ID
300000045010
Created by admin on Wed Apr 02 20:23:07 GMT 2025 , Edited by admin on Wed Apr 02 20:23:07 GMT 2025
PRIMARY
INN
13044
Created by admin on Wed Apr 02 20:23:07 GMT 2025 , Edited by admin on Wed Apr 02 20:23:07 GMT 2025
PRIMARY
NCI_THESAURUS
C207225
Created by admin on Wed Apr 02 20:23:07 GMT 2025 , Edited by admin on Wed Apr 02 20:23:07 GMT 2025
PRIMARY
FDA UNII
XUA5T4H9TM
Created by admin on Wed Apr 02 20:23:07 GMT 2025 , Edited by admin on Wed Apr 02 20:23:07 GMT 2025
PRIMARY
Related Record Type Details
TARGET->CONJUGATED TOXIN
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE EXPANSION BIOLOGICAL INTERLEUKIN-7 HUMAN RECOMBINANT 418XB47Y71
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Osencabtagene autoleucel lentiviral vector with anti-CD7 chimeric antigen receptor (CAR) gene FU5PMT99YY
CULTURE ACTIVATOR BIOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Osencabtagene autoleucel lentiviral vector with CD7-blocking gene 7MX7Z5GUU5
CULTURE EXPANSION BIOLOGICAL INTERLEUKIN 15, RECOMBINANT NON-GLYCOSYLATED 6D6TDU4V9X

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Osencabtagene autoleucel expressed CD7-CAR A53DU8F9L6
INSERTED GENE EXPRESSION VECTOR Osencabtagene autoleucel transgene insert encoding CD7-CAR YV6VUA7GDY
INSERTED GENE EXPRESSION VECTOR Osencabtagene autoleucel transgene insert encoding bivalent anti-CD7 nano-antibody sequence endoplasmic reticulum retention sequence (CD7-blocking gene) JUE5XG7E5Z
VECTOR EXPRESSED PROTEIN Osencabtagene autoleucel expressed bivalent anti-CD7 nano-antibody sequence endoplasmic reticulum retention sequence (CD7-blocking gene) 7PQ69TH9VF
Name Property Type Amount Referenced Substance Defining Parameters References
ANTIGEN NOT EXPRESSED BIOLOGICAL
ANTIGEN EXPRESSED BIOLOGICAL