Table 1. CD19-directed CAR T-cell... | American Society of Hematology

Table 1.

CD19-directed CAR T-cell products for DLBCL: 1-year outcomes

	Axicabtagene ciloleucel ZUMA-1 trial^3,4			Tisagenlecleucel JULIET trial^5,6		Lisocabtagene maraleucel TRANSCEND NHL 001 trial¹⁰
US FDA approved	Yes			Yes		No
CAR construct	Anti-CD19, CD28, CD3z			Anti-CD19, 4-1BB, CD3z		Anti-CD19, 4-1BB, CD3z (tEGFR)
Costimulatory domain	CD28			4-1BB		4-1BB
Vector	Retrovirus			Lentivirus		Lentivirus
CAR T-cell manufacturing	Bulk, fresh			Bulk, cryopreserved		CD8⁺ and CD4⁺ T cells: separate, fresh
CAR T-cell dose	2.0 × 10⁶ cells/kg, max 2.0 × 10⁸ cells			0.6-6 × 10⁸ cells		1.0 × 10⁸ CD8⁺ and CD4⁺ cells
Bridging therapy	No			Yes: 92%		Yes: 59%
Lymphodepletion	Flu/Cy (30 mg/m², 500 mg/m²) × 3 d			Flu/Cy (25 mg/m², 250 mg/m²) × 3 d or bendamustine (90 mg/m²) × 2 d		Flu/Cy (30 mg/m², 300 mg/m²) × 3 d
Secondary CNS lymphoma	No			No		Yes: small number
ALC cutoff for manufacturing, per µL	ALC ≥100			ALC ≥300		None
Lymphoma subtypes enrolled	DLBCL/HGBCL	PMBL	tFL	DLBCL/ HGBCL	tFL	DLBCL	HGBCL	t-iNHL	PMBL	FL3B
Evaluable patients, n	77	8	16	89	22	137	36	78	15	3
Follow-up time, mo	15.4			14		12.3
Efficacy, n	101			93		256
Best ORR, % (CR%)	82 (54)			52 (40)		73 (53)
DOR at 12 mo	11.1 mo/NR*			NR		NR (all patients)
DOR at 12 mo	11.1 mo/NR*			NR		5.6 mo	10.8 mo	NR (tFL)	NR	—
DOR for CR at 12 mo	NR			NR		NR
OS at 12 mo, %	59			49		58
Median follow-up for trial, mo	27			24		12
Safety, n	101			111		269
CRS ≥grade 3, %	13†			22‡		2‡
CRS time to onset median duration (range)	2 d (range, 1-12)			3 d (range, 1-9)		5 d (range, 1-14)
CRS time to onset median duration (range)	8 d (not reported)			7 d (range, 2-30)		5 d (1-17)
Neurotoxicity ≥grade 3, %	28			12		10
Neurotoxicity time to onset median duration (range)	5 d (range, 1-17)			6 d (range, 1-17)		9 d (range 1-66)
Neurotoxicity time to onset median duration (range)	not reported			14 d (not reported)		11 d (range, 1-86)

	Axicabtagene ciloleucel ZUMA-1 trial^3,4			Tisagenlecleucel JULIET trial^5,6		Lisocabtagene maraleucel TRANSCEND NHL 001 trial¹⁰
US FDA approved	Yes			Yes		No
CAR construct	Anti-CD19, CD28, CD3z			Anti-CD19, 4-1BB, CD3z		Anti-CD19, 4-1BB, CD3z (tEGFR)
Costimulatory domain	CD28			4-1BB		4-1BB
Vector	Retrovirus			Lentivirus		Lentivirus
CAR T-cell manufacturing	Bulk, fresh			Bulk, cryopreserved		CD8⁺ and CD4⁺ T cells: separate, fresh
CAR T-cell dose	2.0 × 10⁶ cells/kg, max 2.0 × 10⁸ cells			0.6-6 × 10⁸ cells		1.0 × 10⁸ CD8⁺ and CD4⁺ cells
Bridging therapy	No			Yes: 92%		Yes: 59%
Lymphodepletion	Flu/Cy (30 mg/m², 500 mg/m²) × 3 d			Flu/Cy (25 mg/m², 250 mg/m²) × 3 d or bendamustine (90 mg/m²) × 2 d		Flu/Cy (30 mg/m², 300 mg/m²) × 3 d
Secondary CNS lymphoma	No			No		Yes: small number
ALC cutoff for manufacturing, per µL	ALC ≥100			ALC ≥300		None
Lymphoma subtypes enrolled	DLBCL/HGBCL	PMBL	tFL	DLBCL/ HGBCL	tFL	DLBCL	HGBCL	t-iNHL	PMBL	FL3B
Evaluable patients, n	77	8	16	89	22	137	36	78	15	3
Follow-up time, mo	15.4			14		12.3
Efficacy, n	101			93		256
Best ORR, % (CR%)	82 (54)			52 (40)		73 (53)
DOR at 12 mo	11.1 mo/NR*			NR		NR (all patients)
DOR at 12 mo	11.1 mo/NR*			NR		5.6 mo	10.8 mo	NR (tFL)	NR	—
DOR for CR at 12 mo	NR			NR		NR
OS at 12 mo, %	59			49		58
Median follow-up for trial, mo	27			24		12
Safety, n	101			111		269
CRS ≥grade 3, %	13†			22‡		2‡
CRS time to onset median duration (range)	2 d (range, 1-12)			3 d (range, 1-9)		5 d (range, 1-14)
CRS time to onset median duration (range)	8 d (not reported)			7 d (range, 2-30)		5 d (1-17)
Neurotoxicity ≥grade 3, %	28			12		10
Neurotoxicity time to onset median duration (range)	5 d (range, 1-17)			6 d (range, 1-17)		9 d (range 1-66)
Neurotoxicity time to onset median duration (range)	not reported			14 d (not reported)		11 d (range, 1-86)

Flu/Cy, fludarabine/cyclophosphamide; t-iNHL, transformed indolent non-Hodgkin lymphoma; FL3B: FL grade 3B; NR, not reached.

Per the independent review committee.

†Graded according to the Lee scale.⁵

‡Graded according to the Penn scale.⁴

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