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 16:33:11 UTC 2023
Edited
by admin
on Sat Dec 16 16:33:11 UTC 2023
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part BLOOD CELL
Fraction Material Type CELL
Fraction Name T-CELLS
Record UNII
EJG3KK52YP
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Rapcabtagene Autoleucel
USAN   INN  
Official Name English
Autologous T cells obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, nonreplicating lentiviral vector, encoding a T cell chimeric antigen receptor targeting CD19. The expressed transgene comprises a C
Chemical Description English
YTB-323
Code English
ANTI-CD19 CAR-T CELL THERAPY YTB323
Common Name English
RAPCABTAGENE AUTOLEUCEL [USAN]
Common Name English
YTB323
Code English
Code System Code Type Description
USAN
LM-110
Created by admin on Sat Dec 16 16:33:11 UTC 2023 , Edited by admin on Sat Dec 16 16:33:11 UTC 2023
PRIMARY
INN
11974
Created by admin on Sat Dec 16 16:33:11 UTC 2023 , Edited by admin on Sat Dec 16 16:33:11 UTC 2023
PRIMARY
FDA UNII
EJG3KK52YP
Created by admin on Sat Dec 16 16:33:11 UTC 2023 , Edited by admin on Sat Dec 16 16:33:11 UTC 2023
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
TARGET->CYTOTOXIC T-CELL
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
TICELL ACTIVATION EXPANSION BIOLOGICAL T CELL TRANSACT, HUMAN YG578HEY4V
T-CELL SELECTION TARGETED ANTIGEN IMMUNOLOGICAL UNSPECIFIED SUBSTANCE 5c1f06ef
T-CELL SELECTION TARGETED ANTIGENS IMMUNOLOGICAL UNSPECIFIED SUBSTANCE 2399a508
TRANSFECTION FOLLOWED BY EXPANSION AND RELEASE FROM MAGNETIC BEADS RECEPTOR EXPRESSION RETROVIRAL TRANSFECTION UNSPECIFIED SUBSTANCE d5204918
CULTURE EXPANSION BIOLOGICAL HUMAN INTERLEUKIN 2, RECOMBINANT NON-GLYCOSYLATED 72WT6YGC0U

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN TISAGENLECLEUCEL CAR-T RECEPTOR E1A4B5F3ZQ
Name Property Type Amount Referenced Substance Defining Parameters References
Tmax PHARMACOKINETIC TISSUE MEASURED
PHARMACOKINETIC
CD4/CD8 RATIO BIOLOGICAL