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 20:33:22 GMT 2025
Edited
by admin
on Wed Apr 02 20:33:22 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part blood
Fraction Name cd4+/cd8+ enriched t cells
Record UNII
T2ZFF62NQ9
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous T lymphocytes from peripheral blood obtained by leukapheresis, transduced with four self-inactivating, nonreplicating lentiviral vectors encoding (i) a chimeric antigen receptor (CAR) targeting guanylyl cyclase C (GC-C, GUCY2C), (ii) a chimeri
Preferred Name English
Elzocabtagene Autoleucel
INN  
Official Name English
elzocabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
FDA UNII
T2ZFF62NQ9
Created by admin on Wed Apr 02 20:33:22 GMT 2025 , Edited by admin on Wed Apr 02 20:33:22 GMT 2025
PRIMARY
NCI_THESAURUS
C211708
Created by admin on Wed Apr 02 20:33:22 GMT 2025 , Edited by admin on Wed Apr 02 20:33:22 GMT 2025
PRIMARY
INN
12959
Created by admin on Wed Apr 02 20:33:22 GMT 2025 , Edited by admin on Wed Apr 02 20:33:22 GMT 2025
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
TARGET->CYTOTOXIC T-CELL
Related Record Type Details
ACTIVE MOIETY
The T lymphocytes (>75%) are positive for the transgenes (>5% CAR positive), with less than 0.5 % CD19+ cells. The cells produce cytokines (interleukin-6, interleukin-12, and interferon gamma) in co-culture with B lymphocytes

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Elzocabtagene autoleucel vector (anti-CD19 CAR + IL-12-VHL) JJF47U33ZR
CULTURE EXPANSION BIOLOGICAL HUMAN INTERLEUKIN-2 FNO32LO217
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Elzocabtagene autoleucel vector (anti-GCC CAR) 7N8HP7B54Z
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Elzocabtagene autoleucel vector (anti-CD19 CAR + IFN-?) LN3CN73GKK
CULTURE ACTIVATOR BIOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Elzocabtagene autoleucel vector (anti-CD19 CAR + IL-6) RMG8AY883S

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
INSERTED GENE EXPRESSION VECTOR Elzocabtagene autoleucel anti-GCC CAR transgene insert Q643USN4GW
VECTOR EXPRESSED PROTEIN Elzocabtagene autoleucel expressed anti-GCC CAR 78UGX6H8Q7
VECTOR EXPRESSED PROTEIN Elzocabtagene autoleucel expressed interferon gamma (IFN-?) 9Q2AP23HRD
VECTOR EXPRESSED PROTEIN HUMAN INTERLEUKIN-6 4O4QWG0B3C
INSERTED GENE EXPRESSION VECTOR Elzocabtagene autoleucel anti-CD19 CAR + IFN-? transgene insert 49E9RPQ8S6
INSERTED GENE EXPRESSION VECTOR Elzocabtagene autoleucel anti-CD19 CAR + IL-6 transgene insert EBG6T54TTZ
VECTOR EXPRESSED PROTEIN Elzocabtagene autoleucel expressed anti-CD19 CAR 6UR5HYQ28B
VECTOR EXPRESSED PROTEIN Elzocabtagene autoleucel expressed IL-12-VHL preprotein FHY3SU39ZU
INSERTED GENE EXPRESSION VECTOR Elzocabtagene autoleucel anti-CD19 CAR + IL-12-VHL transgene insert UC3TL3H2HQ
Name Property Type Amount Referenced Substance Defining Parameters References
ANTIGEN LOW EXPRESSION BIOLOGICAL