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 17:59:58 GMT 2025
Edited
by admin
on Wed Apr 02 17:59:58 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part blood
Fraction Name t cells enriched for cd4/cd8
Record UNII
4BEJ6K4DQ9
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Autologous T lymphocytes obtained from peripheral blood by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human CD22. The expressed transgene comprises the granul
Preferred Name English
Firicabtagene Autoleucel
INN   USAN  
Official Name English
firicabtagene autoleucel [INN]
Common Name English
FIRICABTAGENE AUTOLEUCEL [USAN]
Common Name English
Code System Code Type Description
SMS_ID
300000054849
Created by admin on Wed Apr 02 17:59:58 GMT 2025 , Edited by admin on Wed Apr 02 17:59:58 GMT 2025
PRIMARY
NCI_THESAURUS
C203126
Created by admin on Wed Apr 02 17:59:58 GMT 2025 , Edited by admin on Wed Apr 02 17:59:58 GMT 2025
PRIMARY
USAN
MN-211
Created by admin on Wed Apr 02 17:59:58 GMT 2025 , Edited by admin on Wed Apr 02 17:59:58 GMT 2025
PRIMARY
FDA UNII
4BEJ6K4DQ9
Created by admin on Wed Apr 02 17:59:58 GMT 2025 , Edited by admin on Wed Apr 02 17:59:58 GMT 2025
PRIMARY
INN
12829
Created by admin on Wed Apr 02 17:59:58 GMT 2025 , Edited by admin on Wed Apr 02 17:59:58 GMT 2025
PRIMARY
Related Record Type Details
CONSTITUENT MAY BE PRESENT -> PARENT
secrete interferon gamma in esponse to CD22 expressing tumour cell lines
TARGET -> INHIBITOR
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
CULTURE EXPANSION BIOLOGICAL HUMAN AB SERUM S6RLS52G3S
CULTURE EXPANSION BIOLOGICAL HUMAN IL-15 HRJ300HC9W
CULTURE ACTIVATOR BIOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Firicabtagene autoleucel lentiviral vector QDR2XGC8SL

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
INSERTED GENE EXPRESSION VECTOR Firicabtagene autoleucel transgene insert A65Z4B94MY
VECTOR EXPRESSED PROTEIN Firicabtagene autoleucel expressed chimeric antigen receptor (CAR) targeting human CD22 XTR2W4N9GV
Name Property Type Amount Referenced Substance Defining Parameters References
ANTIGEN EXPRESSED BIOLOGICAL