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 17:09:42 GMT 2025
Edited
by admin
on Wed Apr 02 17:09:42 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 cells
Fraction Name peripheral blood mononuclear cells (pbmcs)
Record UNII
W3X22HS7XD
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Allogeneic T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis of healthy volunteer donors, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human CD19
Preferred Name English
Cemacabtagene Ansegedleucel
INN  
Official Name English
cemacabtagene ansegedleucel [INN]
Common Name English
Code System Code Type Description
FDA UNII
W3X22HS7XD
Created by admin on Wed Apr 02 17:09:42 GMT 2025 , Edited by admin on Wed Apr 02 17:09:42 GMT 2025
PRIMARY
NCI_THESAURUS
C172708
Created by admin on Wed Apr 02 17:09:42 GMT 2025 , Edited by admin on Wed Apr 02 17:09:42 GMT 2025
PRIMARY
INN
12556
Created by admin on Wed Apr 02 17:09:42 GMT 2025 , Edited by admin on Wed Apr 02 17:09:42 GMT 2025
PRIMARY
SMS_ID
300000026952
Created by admin on Wed Apr 02 17:09:42 GMT 2025 , Edited by admin on Wed Apr 02 17:09:42 GMT 2025
PRIMARY
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE BIOLOGICAL Glutamine 0RH81L854J
CULTURE ACTIVATOR BIOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M
CULTURE BIOLOGICAL HUMAN AB SERUM S6RLS52G3S
CULTURE BIOLOGICAL HUMAN INTERLEUKIN-2 FNO32LO217

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Cemacabtagene ansegedleucel expressed CD19-targeted chimeric antigen receptor (CAR) ZH3JN358BG
PROTEIN NOT EXPRESSED (GENE DISRUPTION) CD52 gene CAMPATH-1 ANTIGEN 80A297KX6N
PROTEIN NOT EXPRESSED (GENE DISRUPTION) T cell receptor alpha constant T CELL RECEPTOR ALPHA CHAIN CONSTANT 782D7EP5JS
INSERTED GENE EXPRESSION VECTOR Cemacabtagene ansegedleucel transgene insert RRU79X3ZZQ