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 15:41:21 GMT 2023
Edited
by admin
on Sat Dec 16 15:41:21 GMT 2023
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part BLOOD
Fraction Name T CELLS
Record UNII
NT3BAN5MDV
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ZAMTOCABTAGENE AUTOLEUCEL
INN  
Official Name English
zamtocabtagene autoleucel [INN]
Common Name English
CELLS ARE ACTIVATED IN THE PRESENCE OF A COLLOIDAL POLYMERIC NANOMATRIX COVALENTLY ATTACHED TO ANTI-CD3 AND ANTI-CD28, TRANSDUCED, AND THEN CULTURED IN THE PRESENCE OF IL-7 AND IL-15. THE T CELLS ARE PREDOMINANTLY CENTRAL MEMORY (>80%; CD4+/CD8+, CD62L+,
Common Name English
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD COLLECTED BY LEUKAPHERESIS, TRANSDUCED WITH A NON-REPLICATING LENTIVIRAL VECTOR, PSEUDOTYPED WITH VESICULAR STOMATITIS VIRUS (VSV) GLYCOPROTEIN (G), ENCODING A CODON-OPTIMIZED CHIMERIC ANTIGEN RECEPTOR (C
Common Name English
Code System Code Type Description
FDA UNII
NT3BAN5MDV
Created by admin on Sat Dec 16 15:41:21 GMT 2023 , Edited by admin on Sat Dec 16 15:41:21 GMT 2023
PRIMARY
NCI_THESAURUS
C180596
Created by admin on Sat Dec 16 15:41:21 GMT 2023 , Edited by admin on Sat Dec 16 15:41:21 GMT 2023
PRIMARY
INN
11574
Created by admin on Sat Dec 16 15:41:21 GMT 2023 , Edited by admin on Sat Dec 16 15:41:21 GMT 2023
PRIMARY
Related Record Type Details
ACTIVE MOIETY
Antigen specific killing and cytokine secretion

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
LENTIVIRAL TRANSFECTION TRANSFECTION ZAMTOCABTAGENE AUTOLEUCEL VECTOR GMG3GH6XRC
CULTURE CD4+/CD8 ENRICHMENT CELL SEPARATION

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN ZAMTOCABTAGENE AUTOLEUCEL EXPRESSED ANTI-CD20-CD19 CHIMERIC ANTIGEN RECEPTOR FIF7L4K9BC
INSERTED GENE EXPRESSION VECTOR ZAMTOCABTAGENE AUTOLEUCEL TRANSGENE INSERT 5CF9YS6GEV