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 Sat Dec 16 19:13:55 GMT 2023
Edited
by admin
on Sat Dec 16 19:13:55 GMT 2023
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part BLOOD
Fraction Name CD4/CD8 T cells
Record UNII
WD9M7WQ9SY
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Fencabtagene Autoleucel
INN  
Official Name English
TAC-engineered T cells TAC01-HER2
Common Name English
autologous CD4/CD8 enriched T lymphocytes obtained from peripheral blood by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor targeting human receptor tyrosine-protein kinase erbB-2
Common Name English
Autologous anti-HER2 T-cell antigen coupler-expressing T cells TAC01-HER2
Common Name English
fencabtagene autoleucel [INN]
Common Name English
TACTIC-2
Code English
Code System Code Type Description
FDA UNII
WD9M7WQ9SY
Created by admin on Sat Dec 16 19:13:55 GMT 2023 , Edited by admin on Sat Dec 16 19:13:55 GMT 2023
PRIMARY
INN
12821
Created by admin on Sat Dec 16 19:13:55 GMT 2023 , Edited by admin on Sat Dec 16 19:13:55 GMT 2023
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
Related Record Type Details
ACTIVE MOIETY
A preparation of autologous T lymphocytes that are genetically engineered with a T-cell Antigen Coupler (TAC), comprising of a domain that targets the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 (HER2) and another domain that binds to the endogenous T-cell receptor (TCR), with potential immunostimulating and antineoplastic activities.