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 02:25:04 GMT 2025
Edited
by admin
on Wed Apr 02 02:25:04 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part blood
Fraction Material Type cell
Fraction Name t-cells
Record UNII
1T1JX1GA68
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ITEZOCABTAGENE AUTOLEUCEL
INN  
Official Name English
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A NON-REPLICATING MOLONEY MURINE LEUKAEMIA VIRUS (MMLV) VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) UNDER THE CONTROL OF THE 5' LONG TERMINAL REP
Preferred Name English
itezocabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
INN
11887
Created by admin on Wed Apr 02 02:25:04 GMT 2025 , Edited by admin on Wed Apr 02 02:25:04 GMT 2025
PRIMARY
SMS_ID
300000039128
Created by admin on Wed Apr 02 02:25:04 GMT 2025 , Edited by admin on Wed Apr 02 02:25:04 GMT 2025
PRIMARY
FDA UNII
1T1JX1GA68
Created by admin on Wed Apr 02 02:25:04 GMT 2025 , Edited by admin on Wed Apr 02 02:25:04 GMT 2025
PRIMARY
NCI_THESAURUS
C203128
Created by admin on Wed Apr 02 02:25:04 GMT 2025 , Edited by admin on Wed Apr 02 02:25:04 GMT 2025
PRIMARY
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
ACTIVATION ACTIVATOR IMMUNOLOGICAL MACS GMP CD28 PURE ZL3BS1J3LY
ACTIVATION ACTIVATOR IMMUNOLOGICAL MUROMONAB-CD3 JGA39ICE2V
CAR T-EXPRESSION TRANSFECTION RETROVIRAL TRANSFECTION ITEZOCABTAGENE AUTOLEUCEL RETROVIRAL VECTOR 627T8INJ04

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN ITEZOCABTAGENE AUTOLEUCEL EXPRESSED CD30 CHIMERIC ANTIGEN RECEPTOR 6D9ZG1S022
INSERTED GENE EXPRESSION VECTOR ITEZOCABTAGENE AUTOLEUCEL TRANSGENE INSERT 5XHL336SCK