Table 1. Patient characteristics and... | American Society of Hematology

Table 1.

Patient characteristics and outcomes following CAR T-cell therapy

Characteristics	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7	Patient 8	Patient 9
Age, y	21	31	55	42	41	30	50	29	39
Sex	M	M	M	M	M	M	M	M	M
Disease stage	IVB	IVB	IVB	IVB	IVB	IVB	IVB	IVB	IVB
No. of prior therapies	2	4	3	3	5	2	5	1	2
Prior lines of therapy	1. R-EPOCH	1. R-EPOCH	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP + enzastaurin	1. R-CHOP
	2. R-GDP	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE		2. R-ICE
		3. R-Len	3. R-GEMOX	3. R-GEMOX	3. ASCT		3. BV + Nivo
		4. R-GEMOX			4. R-DHAP		4. R-GEMOX
					5. R-Len		5. R-Len
Disease status	Primary-refractory	Primary-refractory	Primary-refractory	Primary-refractory	Relapsed	Primary-refractory	Primary-refractory	Relapsed	Primary-refractory
Baseline (Ref. range)
LDH, U/L (116-245 U/L)	872	509	343	577	342	293	*	141	*
CRP, mg/dL (<0.5 mg/dL)	2.8	4.3	7.9	12.4	0.7	0.5	*	0	*
Ferritin, ng/mL (20-300 ng/mL)	1578	242	1142	346	219	275	*	135	*
MTV, mL†	621.52	680.27	2160.83	1799.31	‡	711.1	1690	85.95	‡
ECOG PS	0	0	1	0	0	0	1	0	0
Bridging therapy	No	Yes	Yes	Yes	Yes	No	Yes	No	No
Product§	Axi-cel	Axi-cel	Axi-cel	Axi-cel	Axi-cel	Tisa-cel	Anti-CD19 CAR (clinical trial)	Anti-CD19 CAR (clinical trial)	Axi-cel
CRS	Grade 1	Grade 1	Grade 2	Grade 1	Grade 2	Grade 1	Grade 1	Grade 1	Grade 1
ICANS	Grade 1	Grade 1	Grade 2	Grade 1	Grade 4	Grade 0	Grade 2	Grade 0	Grade 0
Tocilizumab or steroids	No	Tocilizumab	Tocilizumab and steroids	Tocilizumab	Tocilizumab and steroids	No	No	Tocilizumab	No
Disease response assessment\|\|	PET/CT, day 60; PD	PET/CT, day 60; PD	PET/CT, day 30; PD	PET/CT, day 30; PD	PET/CT, day 30; PD	PET/CT, day 90; PD	PET/CT, day 60; PD	PET/CT, day 90; PD	PET/CT, day 30; PD
Response to CAR T-cell therapy	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory
Biopsy confirming relapse	LN biopsy, day 74: T/HRLBCL	RP mass, day 62: T/HRLBCL	Ascites, day 40: T/HRLBCL	Pleural fluid, day 34: LBCL	Bone marrow, day 125: T/HRLBCL	Not performed	Lung lesion, day 84: T/HRLBCL	Lung lesion, day 107: T/HRLBCL	RP mass, day 50: T/HRLBCL
CD19 expression
Pre-CAR T¶	Yes	Yes	Yes	Yes	NA	Yes	Yes	Yes	Yes
Post-CAR T¶	Yes	Yes	Yes	Yes	Yes	NA	NA	NA	NA
Response to subsequent anti–PD-1 therapy	Pembro, PD	Pembro, PD				Pembro, ongoing CR		Nivo, PR	Pembro, PD
Survival status	Alive	Deceased	Deceased	Deceased	Deceased	Alive	Deceased	Alive	Deceased
Assays performed	mIF	mIF		FC	FC mIF, posttreatment	FC	mIF
	PD-L1	PD-L1				PD-L1	PD-L1
	FISH: disomic	FISH: disomic				FISH: amplified	FISH: disomic

Characteristics	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7	Patient 8	Patient 9
Age, y	21	31	55	42	41	30	50	29	39
Sex	M	M	M	M	M	M	M	M	M
Disease stage	IVB	IVB	IVB	IVB	IVB	IVB	IVB	IVB	IVB
No. of prior therapies	2	4	3	3	5	2	5	1	2
Prior lines of therapy	1. R-EPOCH	1. R-EPOCH	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP	1. R-CHOP + enzastaurin	1. R-CHOP
	2. R-GDP	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE	2. R-ICE		2. R-ICE
		3. R-Len	3. R-GEMOX	3. R-GEMOX	3. ASCT		3. BV + Nivo
		4. R-GEMOX			4. R-DHAP		4. R-GEMOX
					5. R-Len		5. R-Len
Disease status	Primary-refractory	Primary-refractory	Primary-refractory	Primary-refractory	Relapsed	Primary-refractory	Primary-refractory	Relapsed	Primary-refractory
Baseline (Ref. range)
LDH, U/L (116-245 U/L)	872	509	343	577	342	293	*	141	*
CRP, mg/dL (<0.5 mg/dL)	2.8	4.3	7.9	12.4	0.7	0.5	*	0	*
Ferritin, ng/mL (20-300 ng/mL)	1578	242	1142	346	219	275	*	135	*
MTV, mL†	621.52	680.27	2160.83	1799.31	‡	711.1	1690	85.95	‡
ECOG PS	0	0	1	0	0	0	1	0	0
Bridging therapy	No	Yes	Yes	Yes	Yes	No	Yes	No	No
Product§	Axi-cel	Axi-cel	Axi-cel	Axi-cel	Axi-cel	Tisa-cel	Anti-CD19 CAR (clinical trial)	Anti-CD19 CAR (clinical trial)	Axi-cel
CRS	Grade 1	Grade 1	Grade 2	Grade 1	Grade 2	Grade 1	Grade 1	Grade 1	Grade 1
ICANS	Grade 1	Grade 1	Grade 2	Grade 1	Grade 4	Grade 0	Grade 2	Grade 0	Grade 0
Tocilizumab or steroids	No	Tocilizumab	Tocilizumab and steroids	Tocilizumab	Tocilizumab and steroids	No	No	Tocilizumab	No
Disease response assessment\|\|	PET/CT, day 60; PD	PET/CT, day 60; PD	PET/CT, day 30; PD	PET/CT, day 30; PD	PET/CT, day 30; PD	PET/CT, day 90; PD	PET/CT, day 60; PD	PET/CT, day 90; PD	PET/CT, day 30; PD
Response to CAR T-cell therapy	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory	Refractory
Biopsy confirming relapse	LN biopsy, day 74: T/HRLBCL	RP mass, day 62: T/HRLBCL	Ascites, day 40: T/HRLBCL	Pleural fluid, day 34: LBCL	Bone marrow, day 125: T/HRLBCL	Not performed	Lung lesion, day 84: T/HRLBCL	Lung lesion, day 107: T/HRLBCL	RP mass, day 50: T/HRLBCL
CD19 expression
Pre-CAR T¶	Yes	Yes	Yes	Yes	NA	Yes	Yes	Yes	Yes
Post-CAR T¶	Yes	Yes	Yes	Yes	Yes	NA	NA	NA	NA
Response to subsequent anti–PD-1 therapy	Pembro, PD	Pembro, PD				Pembro, ongoing CR		Nivo, PR	Pembro, PD
Survival status	Alive	Deceased	Deceased	Deceased	Deceased	Alive	Deceased	Alive	Deceased
Assays performed	mIF	mIF		FC	FC mIF, posttreatment	FC	mIF
	PD-L1	PD-L1				PD-L1	PD-L1
	FISH: disomic	FISH: disomic				FISH: amplified	FISH: disomic

ASCT, autologous stem cell transplant; BV, brentuximab vedotin; CR, complete response; CRP, C-reactive protein; CRS, cytokine release syndrome; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FC, flow cytometry; FISH, fluorescence in situ hybridization; ICANS, immune effector cell-associated neurotoxicity syndrome; LBCL, large B-cell lymphoma; LDH, lactate dehydrogenase; LN, lymph node; M, male; mIF, multispectral immunofluorescence; MTV, metabolic tumor volume; NA, not assessed; nivo, nivolumab; PD, progressive disease; Pembro, pembrolizumab; PET/CT, positron emission tomography/computed tomography; PR, partial response; R-CHOP, rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone; R-DHAP, rituximab, dexamethasone, ara-C, cisplatin; Ref., reference; R-EPOCH, rituximab, etoposide, prednisone, oncovin, cyclophosphamide, hydroxydaunorubicin; R-GDP, rituximab, gemcitabine, dexamethasone, cisplatin; R-GEMOX, rituximab, gemcitabine, oxaliplatin; R-ICE, rituximab, ifosfamide, carboplatin, etoposide; R-Len, rituximab, lenalidomide; RP, retroperitoneal.

LDH, CRP, and ferritin levels unavailable.

†

MTV indicates that whole-body metabolic tumor volume was ascertained from fluorodeoxyglucose (FDG)-PET/CT imaging.

‡

PET/CT imaging unavailable for MTV calculation.

Lymphodepleting chemotherapy regimen administered: patients 1 through 5 and 7 through 9 received fludarabine (30 mg/m² on days −5, −4, −3) and cyclophosphamide (500 mg/m² on days −5, −4, −3); patient 6 received fludarabine (25 mg/m² per day on days −5, −4, −3) and cyclophosphamide (250 mg/m² per day on days −5, −4, −3).

Patients 7 and 8 achieved PR at day 30 and subsequently progressed by day 60 and day 90, respectively. All other patients experienced disease progression at their first response assessment at the indicated time points.

NA denotes patients in whom CD19 expression on tumor tissue could not be assessed due to tissue exhaustion.

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