Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-07-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
nanograms per liter
Interval / dispersion
Standard Error
Time frame
Pre-infusion and 2 hours post infusion on Day 1, Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100
What was measured
Serum systemic cytokine concentrations (Interleukin \[IL\]-6, IL-10, and Interferon Gamma \[IFN-g\]) were reported.
Analysis population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points for specified categories.
Groups in this outcome
Phase 1b (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
Phase 2 (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
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
Phase 1b (US Population)
29
Phase 2 (US Population)
68
Phase 2 (Japan Population)
9
Reported measurements
Interleukin 6: Day 1 (Pre-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
3.66
4.280
Not reported
Not reported
Not reported
Phase 2 (US Population)
3.81
4.231
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.62
1.597
Not reported
Not reported
Not reported
Interleukin 6: Day 1 (2 hours post-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
23
Phase 2 (US Population)
31
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
3.59
3.892
Not reported
Not reported
Not reported
Phase 2 (US Population)
4.05
4.158
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.76
1.602
Not reported
Not reported
Not reported
Interleukin 6: Day 2
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
1
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
4.62
Not reported
Not reported
Not reported
Not reported
Phase 2 (US Population)
6.47
6.783
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
2.74
2.268
Not reported
Not reported
Not reported
Interleukin 6: Day 3
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
7.31
12.849
Not reported
Not reported
Not reported
Phase 2 (US Population)
25.57
110.008
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
3.87
4.360
Not reported
Not reported
Not reported
Interleukin 6: Day 7
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
25.43
68.141
Not reported
Not reported
Not reported
Phase 2 (US Population)
200.93
434.850
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
128.50
367.531
Not reported
Not reported
Not reported
Interleukin 6: Day 10
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
247.99
464.936
Not reported
Not reported
Not reported
Phase 2 (US Population)
227.01
405.250
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
108.05
171.088
Not reported
Not reported
Not reported
Interleukin 6: Day 14
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
42.03
63.840
Not reported
Not reported
Not reported
Phase 2 (US Population)
110.94
512.499
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
20.62
17.898
Not reported
Not reported
Not reported
Interleukin 6: Day 21
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
68
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
227.45
989.332
Not reported
Not reported
Not reported
Phase 2 (US Population)
69.33
291.552
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
14.25
15.439
Not reported
Not reported
Not reported
Interleukin 6: Day 28
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
67.89
129.381
Not reported
Not reported
Not reported
Phase 2 (US Population)
110.86
593.155
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
18.73
26.593
Not reported
Not reported
Not reported
Interleukin 6: Day 42
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
61
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
56.16
153.528
Not reported
Not reported
Not reported
Phase 2 (US Population)
141.33
908.434
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
12.23
10.830
Not reported
Not reported
Not reported
Interleukin 6: Day 56
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
12.44
34.311
Not reported
Not reported
Not reported
Phase 2 (US Population)
113.28
749.566
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
8.12
8.594
Not reported
Not reported
Not reported
Interleukin 6: Day 78
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
62
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
56.25
164.152
Not reported
Not reported
Not reported
Phase 2 (US Population)
137.01
753.322
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
3.91
6.280
Not reported
Not reported
Not reported
Interleukin 6: Day 100
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
24
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.36
1.680
Not reported
Not reported
Not reported
Phase 2 (US Population)
239.64
1491.202
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.45
1.123
Not reported
Not reported
Not reported
Interleukin 10: Day 1 (pre-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
1.19
1.170
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.68
2.749
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.07
0.795
Not reported
Not reported
Not reported
Interleukin 10: Day 1 (2 hours post-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
26
Phase 2 (US Population)
31
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
1.11
0.924
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.94
3.406
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.07
0.795
Not reported
Not reported
Not reported
Interleukin 10: Day 2
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
1
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.85
Not reported
Not reported
Not reported
Not reported
Phase 2 (US Population)
3.86
6.114
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.90
1.695
Not reported
Not reported
Not reported
Interleukin 10: Day 3
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.65
2.931
Not reported
Not reported
Not reported
Phase 2 (US Population)
4.54
8.318
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
2.10
1.820
Not reported
Not reported
Not reported
Interleukin 10: Day 7
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
27.95
30.506
Not reported
Not reported
Not reported
Phase 2 (US Population)
56.32
81.383
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
89.21
163.729
Not reported
Not reported
Not reported
Interleukin 10: Day 10
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
36.44
56.307
Not reported
Not reported
Not reported
Phase 2 (US Population)
53.78
156.803
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
102.71
184.878
Not reported
Not reported
Not reported
Interleukin 10: Day 14
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
66
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
20.50
90.471
Not reported
Not reported
Not reported
Phase 2 (US Population)
6.99
15.549
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
6.20
6.257
Not reported
Not reported
Not reported
Interleukin 10: Day 21
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
68
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
5.14
5.496
Not reported
Not reported
Not reported
Phase 2 (US Population)
5.36
14.437
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.06
0.560
Not reported
Not reported
Not reported
Interleukin 10: Day 28
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.30
1.345
Not reported
Not reported
Not reported
Phase 2 (US Population)
3.45
6.740
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
2.19
1.917
Not reported
Not reported
Not reported
Interleukin 10: Day 42
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
61
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.36
3.270
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.94
2.682
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.52
0.853
Not reported
Not reported
Not reported
Interleukin 10: Day 56
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
2.17
2.540
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.54
0.967
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
2.38
2.715
Not reported
Not reported
Not reported
Interleukin 10: Day 78
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
62
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
1.84
2.181
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.64
1.499
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
1.08
0.552
Not reported
Not reported
Not reported
Interleukin 10: Day 100
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
24
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
1.45
0.881
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.91
1.920
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
0.72
0.272
Not reported
Not reported
Not reported
Interferon Gamma: Day1 (pre-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
13.37
14.658
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.68
2.749
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
25.29
15.168
Not reported
Not reported
Not reported
Interferon Gamma: Day1 (2 hours post-infusion)
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
26
Phase 2 (US Population)
31
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
21.68
30.670
Not reported
Not reported
Not reported
Phase 2 (US Population)
35.50
53.105
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
25.29
15.168
Not reported
Not reported
Not reported
Interferon Gamma: Day 2
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
1
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
50.87
Not reported
Not reported
Not reported
Not reported
Phase 2 (US Population)
3.86
6.114
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
48.01
30.732
Not reported
Not reported
Not reported
Interferon Gamma: Day 3
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
57.95
59.699
Not reported
Not reported
Not reported
Phase 2 (US Population)
4.54
8.318
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
44.83
48.154
Not reported
Not reported
Not reported
Interferon Gamma: Day 7
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
284.86
397.735
Not reported
Not reported
Not reported
Phase 2 (US Population)
56.32
81.383
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
9043.92
26714.417
Not reported
Not reported
Not reported
Interferon Gamma: Day 10
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
67
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
4095.68
12586.211
Not reported
Not reported
Not reported
Phase 2 (US Population)
53.78
156.803
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
5351.97
11598.493
Not reported
Not reported
Not reported
Interferon Gamma: Day 14
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
66
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
44.58
41.813
Not reported
Not reported
Not reported
Phase 2 (US Population)
6.99
15.549
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
59.50
48.748
Not reported
Not reported
Not reported
Interferon Gamma: Day 21
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
68
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
108.39
113.492
Not reported
Not reported
Not reported
Phase 2 (US Population)
5.36
14.437
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
28.70
22.852
Not reported
Not reported
Not reported
Interferon Gamma: Day 28
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
57.44
82.982
Not reported
Not reported
Not reported
Phase 2 (US Population)
3.45
6.740
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
44.36
45.668
Not reported
Not reported
Not reported
Interferon Gamma: Day 42
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
28
Phase 2 (US Population)
61
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
32.69
39.456
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.94
2.682
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
22.76
22.233
Not reported
Not reported
Not reported
Interferon Gamma: Day 56
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
27
Phase 2 (US Population)
64
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
50.58
143.096
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.54
0.967
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
19.88
32.794
Not reported
Not reported
Not reported
Interferon Gamma: Day 78
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
29
Phase 2 (US Population)
62
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
26.19
34.120
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.64
1.499
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
7.71
4.433
Not reported
Not reported
Not reported
Interferon Gamma: Day 100
Analysis denominator · Participants
Group
Source count
Phase 1b (US Population)
24
Phase 2 (US Population)
65
Phase 2 (Japan Population)
9
Values in nanograms per liter · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Phase 1b (US Population)
18.51
18.052
Not reported
Not reported
Not reported
Phase 2 (US Population)
1.91
1.920
Not reported
Not reported
Not reported
Phase 2 (Japan Population)
9.04
4.958
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
4.280
value
3.66
group Id
OG001
spread
4.231
value
3.81
group Id
OG002
spread
1.597
value
1.62
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
67
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 1 (Pre-infusion)
categories
measurements
group Id
OG000
spread
3.892
value
3.59
group Id
OG001
spread
4.158
value
4.05
group Id
OG002
spread
1.602
value
1.76
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
31
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 1 (2 hours post-infusion)
categories
measurements
group Id
OG000
value
4.62
group Id
OG001
spread
6.783
value
6.47
group Id
OG002
spread
2.268
value
2.74
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
65
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 2
categories
measurements
group Id
OG000
spread
12.849
value
7.31
group Id
OG001
spread
110.008
value
25.57
group Id
OG002
spread
4.360
value
3.87
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
67
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 3
categories
measurements
group Id
OG000
spread
68.141
value
25.43
group Id
OG001
spread
434.850
value
200.93
group Id
OG002
spread
367.531
value
128.50
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
65
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 7
categories
measurements
group Id
OG000
spread
464.936
value
247.99
group Id
OG001
spread
405.250
value
227.01
group Id
OG002
spread
171.088
value
108.05
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
67
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 10
categories
measurements
group Id
OG000
spread
63.840
value
42.03
group Id
OG001
spread
512.499
value
110.94
group Id
OG002
spread
17.898
value
20.62
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
67
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 14
categories
measurements
group Id
OG000
spread
989.332
value
227.45
group Id
OG001
spread
291.552
value
69.33
group Id
OG002
spread
15.439
value
14.25
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
68
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 21
categories
measurements
group Id
OG000
spread
129.381
value
67.89
group Id
OG001
spread
593.155
value
110.86
group Id
OG002
spread
26.593
value
18.73
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
64
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 28
categories
measurements
group Id
OG000
spread
153.528
value
56.16
group Id
OG001
spread
908.434
value
141.33
group Id
OG002
spread
10.830
value
12.23
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
61
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 42
categories
measurements
group Id
OG000
spread
34.311
value
12.44
group Id
OG001
spread
749.566
value
113.28
group Id
OG002
spread
8.594
value
8.12
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
64
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 56
categories
measurements
group Id
OG000
spread
164.152
value
56.25
group Id
OG001
spread
753.322
value
137.01
group Id
OG002
spread
6.280
value
3.91
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
62
group Id
OG002
value
9
units
Participants
title
Interleukin 6: Day 78
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
68
group Id
OG002
value
9
units
Participants
description
Serum systemic cytokine concentrations (Interleukin \[IL\]-6, IL-10, and Interferon Gamma \[IFN-g\]) were reported.
dispersion Type
Standard Error
groups
description
Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
id
OG000
title
Phase 1b (US Population)
description
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
id
OG001
title
Phase 2 (US Population)
description
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
id
OG002
title
Phase 2 (Japan Population)
param Type
MEAN
population Description
mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points for specified categories.
reporting Status
POSTED
time Frame
Pre-infusion and 2 hours post infusion on Day 1, Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 78, 100
title
Phase 1b and Phase 2: Serum Systemic Cytokine Concentrations
Triangle