Change From Baseline in Selected Chemistry Parameters 1
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
U/L
Interval / dispersion
Standard Deviation
Time frame
baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
What was measured
Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Analysis population: All treated participants with a baseline value and a post-baseline value at the time point
Groups in this outcome
Standard of Care Arm
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Liso-cel Arm
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
76
Liso-cel Arm
88
Reported measurements
Month 1 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
76
Liso-cel Arm
88
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
17.22
25.997
Not reported
Not reported
Not reported
Liso-cel Arm
-0.52
18.337
Not reported
Not reported
Not reported
Month 2 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
4.00
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 3 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
43
Liso-cel Arm
73
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-3.40
22.295
Not reported
Not reported
Not reported
Liso-cel Arm
2.53
13.246
Not reported
Not reported
Not reported
Month 4 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-3.00
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 6 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
31
Liso-cel Arm
65
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
2.81
21.067
Not reported
Not reported
Not reported
Liso-cel Arm
3.08
14.813
Not reported
Not reported
Not reported
Month 9 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
23
Liso-cel Arm
61
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
2.43
20.165
Not reported
Not reported
Not reported
Liso-cel Arm
5.23
16.660
Not reported
Not reported
Not reported
Month 12 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
18
Liso-cel Arm
58
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
0.72
23.542
Not reported
Not reported
Not reported
Liso-cel Arm
4.19
19.653
Not reported
Not reported
Not reported
Month 18 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
20
Liso-cel Arm
53
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
10.40
15.892
Not reported
Not reported
Not reported
Liso-cel Arm
-0.45
10.943
Not reported
Not reported
Not reported
Month 24 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
16
Liso-cel Arm
48
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
7.69
15.134
Not reported
Not reported
Not reported
Liso-cel Arm
1.88
13.211
Not reported
Not reported
Not reported
Month 36 Alanine Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
17
Liso-cel Arm
41
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
12.41
17.429
Not reported
Not reported
Not reported
Liso-cel Arm
13.98
104.054
Not reported
Not reported
Not reported
Month 1 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
75
Liso-cel Arm
87
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
3.38
16.624
Not reported
Not reported
Not reported
Liso-cel Arm
2.03
17.526
Not reported
Not reported
Not reported
Month 2 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
5.00
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 3 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
43
Liso-cel Arm
71
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-6.47
17.248
Not reported
Not reported
Not reported
Liso-cel Arm
-1.24
8.800
Not reported
Not reported
Not reported
Month 4 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
3.00
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 6 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
30
Liso-cel Arm
65
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
1.23
15.911
Not reported
Not reported
Not reported
Liso-cel Arm
1.78
8.550
Not reported
Not reported
Not reported
Month 9 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
22
Liso-cel Arm
60
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
3.68
12.549
Not reported
Not reported
Not reported
Liso-cel Arm
2.12
10.355
Not reported
Not reported
Not reported
Month 12 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
18
Liso-cel Arm
57
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-1.44
16.180
Not reported
Not reported
Not reported
Liso-cel Arm
1.88
13.200
Not reported
Not reported
Not reported
Month 18 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
20
Liso-cel Arm
54
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
4.90
7.663
Not reported
Not reported
Not reported
Liso-cel Arm
-1.22
7.452
Not reported
Not reported
Not reported
Month 24 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
16
Liso-cel Arm
48
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
4.63
9.172
Not reported
Not reported
Not reported
Liso-cel Arm
0.90
10.757
Not reported
Not reported
Not reported
Month 36 Aspartate Aminotransferase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
18
Liso-cel Arm
40
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
9.06
15.117
Not reported
Not reported
Not reported
Liso-cel Arm
14.95
94.651
Not reported
Not reported
Not reported
Month 1 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
70
Liso-cel Arm
73
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-66.7
222.79
Not reported
Not reported
Not reported
Liso-cel Arm
-14.0
203.18
Not reported
Not reported
Not reported
Month 2 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
27.0
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 3 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
40
Liso-cel Arm
64
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-57.2
377.22
Not reported
Not reported
Not reported
Liso-cel Arm
-84.1
183.29
Not reported
Not reported
Not reported
Month 4 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
1
Liso-cel Arm
0
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
117.0
NA
Not reported
Not reported
insufficient number of participants to calculate standard deviation
Month 6 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
25
Liso-cel Arm
56
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-85.5
310.71
Not reported
Not reported
Not reported
Liso-cel Arm
-53.7
183.53
Not reported
Not reported
Not reported
Month 9 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
20
Liso-cel Arm
50
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-85.0
362.52
Not reported
Not reported
Not reported
Liso-cel Arm
-62.0
186.25
Not reported
Not reported
Not reported
Month 12 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
18
Liso-cel Arm
48
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-52.9
74.56
Not reported
Not reported
Not reported
Liso-cel Arm
-41.9
207.30
Not reported
Not reported
Not reported
Month 18 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
17
Liso-cel Arm
43
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-44.1
71.19
Not reported
Not reported
Not reported
Liso-cel Arm
-50.8
133.31
Not reported
Not reported
Not reported
Month 24 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
15
Liso-cel Arm
38
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-45.6
75.04
Not reported
Not reported
Not reported
Liso-cel Arm
-63.3
148.25
Not reported
Not reported
Not reported
Month 36 Lactate Dehydrogenase
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
12
Liso-cel Arm
31
Values in U/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-46.0
85.14
Not reported
Not reported
Not reported
Liso-cel Arm
-59.9
124.62
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
25.997
value
17.22
group Id
OG001
spread
18.337
value
-0.52
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
88
units
Participants
title
Month 1 Alanine Aminotransferase
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
4.00
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
22.295
value
-3.40
group Id
OG001
spread
13.246
value
2.53
denoms
counts
group Id
OG000
value
43
group Id
OG001
value
73
units
Participants
title
Month 3 Alanine Aminotransferase
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-3.00
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 4 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
21.067
value
2.81
group Id
OG001
spread
14.813
value
3.08
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
65
units
Participants
title
Month 6 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
20.165
value
2.43
group Id
OG001
spread
16.660
value
5.23
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
61
units
Participants
title
Month 9 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
23.542
value
0.72
group Id
OG001
spread
19.653
value
4.19
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
58
units
Participants
title
Month 12 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
15.892
value
10.40
group Id
OG001
spread
10.943
value
-0.45
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
53
units
Participants
title
Month 18 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
15.134
value
7.69
group Id
OG001
spread
13.211
value
1.88
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
48
units
Participants
title
Month 24 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
17.429
value
12.41
group Id
OG001
spread
104.054
value
13.98
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
41
units
Participants
title
Month 36 Alanine Aminotransferase
categories
measurements
group Id
OG000
spread
16.624
value
3.38
group Id
OG001
spread
17.526
value
2.03
denoms
counts
group Id
OG000
value
75
group Id
OG001
value
87
units
Participants
title
Month 1 Aspartate Aminotransferase
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
5.00
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 Aspartate Aminotransferase
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
88
units
Participants
description
Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
dispersion Type
Standard Deviation
groups
description
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
id
OG000
title
Standard of Care Arm
description
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
id
OG001
title
Liso-cel Arm
param Type
MEAN
population Description
All treated participants with a baseline value and a post-baseline value at the time point
reporting Status
POSTED
time Frame
baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
title
Change From Baseline in Selected Chemistry Parameters 1
Triangle