Anzutresgene Autoleucel

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 19:08:10 GMT 2025` Edited by `admin` on `Wed Apr 02 19:08:10 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	AUTOLOGOUS HUMAN
Source Materials State	LIVE GENETICALLY MODIFIED
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	blood
Fraction Material Type	CELL
Fraction Name	CD4+ and CD8+ T cells
Record UNII	RQA36PL3ZC
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

Anzutresgene Autoleucel

Official Name

English

anzutresgene autoleucel [INN]

Preferred Name

English

autologous CD4+/CD8+ enriched T lymphocytes transduced with a self-inactivating, non-replicating lentiviral vector encoding a T cell receptor (TCR) specific for the preferentially expressed antigen in melanoma (PRAME). The TCR transgene consists of a TCR

Common Name

English

Code System Code Type Description

INN

13480

Created by admin on Wed Apr 02 19:08:10 GMT 2025 , Edited by admin on Wed Apr 02 19:08:10 GMT 2025

PRIMARY

FDA UNII

RQA36PL3ZC

Created by admin on Wed Apr 02 19:08:10 GMT 2025 , Edited by admin on Wed Apr 02 19:08:10 GMT 2025

PRIMARY

Related Record Type Details


					RQA36PL3ZC

Anzutresgene Autoleucel

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Fragment Name	Fragment ID
CULTURE	EXPANSION	BIOLOGICAL	HUMAN IL-15	HRJ300HC9W
CULTURE	ACTIVATOR	BIOLOGICAL	ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS	PA28ZKP50M
CULTURE	EXPANSION	BIOLOGICAL	HUMAN AB SERUM	S6RLS52G3S
CULTURE	EXPANSION	BIOLOGICAL	INTERLEUKIN-7 HUMAN RECOMBINANT	418XB47Y71
LENTIVIRAL TRANSFECTION	TRANSFECTION	BIOLOGICAL	Anzutresgene autoleucel lentiviral vector	VH8GMD5WFF

Structural Modifications

Modification Type	Fragment Name	Fragment Approval
VECTOR EXPRESSED PROTEIN	Anzutresgene autoleucel expressed T cell receptor specific for PRAME-004	8F6MJZ4UFA
INSERTED GENE EXPRESSION VECTOR	Anzutresgene autoleucel transgene insert	4WS6UXM46L
VECTOR EXPRESSED PROTEIN	Anzutresgene autoleucel expressed preprotein	57EE2LDA6K