AZERCABTAGENE ZAPRELEUCEL

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 11:40:03 GMT 2025` Edited by `admin` on `Wed Apr 02 11:40:03 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	ALLOGENIC HUMAN
Source Materials State	LIVE GENETICALLY MODIFIED
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	blood
Fraction Name	t cells
Record UNII	PFZ3AP93TA
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

AZERCABTAGENE ZAPRELEUCEL

Official Name

English

PBCAR-0191

Preferred Name

English

Allogeneic anti-human-CD19 CAR T cell product derived from healthy donor T cells that are genetically edited to (a) remove the expression of the endogenous T cell receptor (TCR) and (b) insert an anti-CD19 CAR gene, thereby providing the ability to speci

Common Name

English

AZERCABTAGENE ZAPRELEUCEL [USAN]

Common Name

English

Azercabtagene zapreleucel [WHO-DD]

Common Name

English

azercabtagene zapreleucel [INN]

Common Name

English

Adult allogeneic CD4+ and CD8+ enriched T cells transduced with an anti-CD19 chimeric antigen receptor (CAR) that is site-specific integrated into the cellular genome. Adult allogeneic CD4+ and CD8+ enriched T cells, gene edited through the electroporati

Common Name

English

PBCAR0191

Code

English

Classification Tree Code System Code

FDA ORPHAN DRUG

738020

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

Code System Code Type Description

USAN

MN-134

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

PRIMARY

NCI_THESAURUS

C158558

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

PRIMARY

SMS_ID

300000033387

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

PRIMARY

FDA UNII

PFZ3AP93TA

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

PRIMARY

INN

11438

Created by admin on Wed Apr 02 11:40:03 GMT 2025 , Edited by admin on Wed Apr 02 11:40:03 GMT 2025

PRIMARY

Related Record Type Details


					TYR224OK86

CD19 POSITIVE CELLS

TARGET->CYTOTOXIC T-CELL

Amount:

Related Record Type Details


					PFZ3AP93TA

AZERCABTAGENE ZAPRELEUCEL

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
CULTURE				UNSPECIFIED SUBSTANCE	2399a508
CULTURED	ENRICHMENT			UNSPECIFIED SUBSTANCE	5c1f06ef
ADENOVIRUS TRANSFECTION	TRANSFECTION			UNSPECIFIED SUBSTANCE	fe9e4201

Structural Modifications

Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
VECTOR EXPRESSED PROTEIN					UNSPECIFIED SUBSTANCE	ea310732 (not in database)
TRANSGENE					UNSPECIFIED SUBSTANCE	09e71fe3 (not in database)
TRANSGENE					AZERCABTAGENE ZAPRELEUCEL AAV6 GENE INSERT	SU254A6B4S
VECTOR EXPRESSED PROTEIN					AZERCABTAGENE ZAPRELEUCEL CHIMERIC ANTIGEN RECEPTOR	QVM7J6UNJ3

Name	Property Type	Amount	Referenced Substance	Defining	Parameters	References
ANTIGEN EXPRESSED	BIOLOGICAL		`2946IE3VYD` CD8

ANTIGEN EXPRESSED	BIOLOGICAL		`P6CUL02K2A` C-C CHEMOKINE RECEPTOR TYPE 7

ANTIGEN NOT EXPRESSED	BIOLOGICAL		`ZLW14X2D30` CD3

ANTIGEN EXPRESSED	BIOLOGICAL		`8OYI5QX0HL` T-CELL SURFACE GLYCOPROTEIN CD4