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NCT03105336 · OUTCOME

Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: pg/mL
Interval / dispersion: Standard Deviation
Time frame: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

What was measured

Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha.

Analysis population: Participants in the Safety Analysis Set with available data were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel (Follicular Lymphoma)

Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

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
Axicabtagene Ciloleucel (Follicular Lymphoma)	124
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Reported measurements

Serum CXCL10 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	466.32	339.00	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	634.56	539.17	Not reported	Not reported	Not reported

Serum CXCL10 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	499.16	334.85	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	763.99	569.42	Not reported	Not reported	Not reported

Serum CXCL10 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	712.31	543.76	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	962.96	611.23	Not reported	Not reported	Not reported

Serum CXCL10 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	841.62	572.80	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1630.98	563.40	Not reported	Not reported	Not reported

Serum CXCL10 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	474.45	371.95	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	798.28	631.80	Not reported	Not reported	Not reported

Serum CXCL10 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	623.87	535.45	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	964.92	640.57	Not reported	Not reported	Not reported

Serum Granzyme B on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3.58	9.68	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	121.49	623.76	Not reported	Not reported	Not reported

Serum Granzyme B on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.95	7.86	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	46.36	234.23	Not reported	Not reported	Not reported

Serum Granzyme B on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	6.53	11.03	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	74.28	348.53	Not reported	Not reported	Not reported

Serum Granzyme B on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	124
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	76.29	494.66	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	52.87	68.63	Not reported	Not reported	Not reported

Serum Granzyme B on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.73	5.67	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27.21	102.65	Not reported	Not reported	Not reported

Serum Granzyme B on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3.14	5.15	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	17.00	39.90	Not reported	Not reported	Not reported

Serum IFN-gamma on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	9.25	7.17	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	30.29	83.67	Not reported	Not reported	Not reported

Serum IFN-gamma on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	11.20	16.17	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	54.04	140.40	Not reported	Not reported	Not reported

Serum IFN-gamma on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	157.13	326.44	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	292.67	531.54	Not reported	Not reported	Not reported

Serum IFN-gamma on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	139.82	359.84	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	674.34	792.31	Not reported	Not reported	Not reported

Serum IFN-gamma on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	25.98	48.82	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27.16	37.43	Not reported	Not reported	Not reported

Serum IFN-gamma on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	23.96	37.04	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	56.72	108.10	Not reported	Not reported	Not reported

Serum IL-1 RA on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	584.66	400.47	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	627.95	467.39	Not reported	Not reported	Not reported

Serum IL-1 RA on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	677.50	743.22	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	960.41	1342.30	Not reported	Not reported	Not reported

Serum IL-1 RA on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	703.79	772.95	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	848.20	757.98	Not reported	Not reported	Not reported

Serum IL-1 RA on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1125.80	1316.88	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	2492.85	2895.93	Not reported	Not reported	Not reported

Serum IL-1 RA on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	591.72	764.19	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	854.68	1693.69	Not reported	Not reported	Not reported

Serum IL-1 RA on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	653.88	1197.23	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1106.94	1935.55	Not reported	Not reported	Not reported

Serum IL-2 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1.03	0.53	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1.12	0.90	Not reported	Not reported	Not reported

Serum IL-2 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1.20	1.22	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1.16	1.09	Not reported	Not reported	Not reported

Serum IL-2 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	8.01	13.08	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	12.43	34.49	Not reported	Not reported	Not reported

Serum IL-2 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1.67	2.55	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	2.99	3.78	Not reported	Not reported	Not reported

Serum IL-2 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0.95	0.48	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0.93	0.18	Not reported	Not reported	Not reported

Serum IL-2 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0.95	0.50	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1.10	1.06	Not reported	Not reported	Not reported

Serum IL-6 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.71	2.90	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	5.08	8.11	Not reported	Not reported	Not reported

Serum IL-6 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.42	2.27	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	4.14	5.39	Not reported	Not reported	Not reported

Serum IL-6 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	59.30	185.89	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	103.93	281.61	Not reported	Not reported	Not reported

Serum IL-6 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	67.49	197.95	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	206.75	282.31	Not reported	Not reported	Not reported

Serum IL-6 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	20.01	92.15	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	33.00	66.24	Not reported	Not reported	Not reported

Serum IL-6 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	31.02	122.14	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	58.84	169.85	Not reported	Not reported	Not reported

Serum IL-7 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	15.99	7.89	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	15.30	7.13	Not reported	Not reported	Not reported

Serum IL-7 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	27.65	9.62	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28.31	10.15	Not reported	Not reported	Not reported

Serum IL-7 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	26.50	10.22	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27.24	10.82	Not reported	Not reported	Not reported

Serum IL-7 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	23.42	11.28	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	23.28	11.69	Not reported	Not reported	Not reported

Serum IL-7 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	27.25	14.13	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26.38	16.52	Not reported	Not reported	Not reported

Serum IL-7 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	18.45	8.92	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	20.30	10.52	Not reported	Not reported	Not reported

Serum IL-8 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	13.59	15.09	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	13.71	9.11	Not reported	Not reported	Not reported

Serum IL-8 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	21.12	33.53	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	42.71	129.39	Not reported	Not reported	Not reported

Serum IL-8 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	60.27	126.84	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	80.86	154.41	Not reported	Not reported	Not reported

Serum IL-8 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	45.79	86.38	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	37.47	30.74	Not reported	Not reported	Not reported

Serum IL-8 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	16.08	17.14	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	41.41	117.98	Not reported	Not reported	Not reported

Serum IL-8 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	20.36	68.72	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	18.90	13.80	Not reported	Not reported	Not reported

Serum IL-10 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.85	3.76	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	5.11	6.72	Not reported	Not reported	Not reported

Serum IL-10 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1.93	2.29	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1.89	2.18	Not reported	Not reported	Not reported

Serum IL-10 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	9.34	17.60	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	7.39	10.14	Not reported	Not reported	Not reported

Serum IL-10 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	15.01	34.55	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	20.32	20.70	Not reported	Not reported	Not reported

Serum IL-10 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.06	4.64	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	3.42	4.88	Not reported	Not reported	Not reported

Serum IL-10 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	1.10	1.31	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	1.65	2.08	Not reported	Not reported	Not reported

Serum IL-15 on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.70	2.69	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	2.59	1.42	Not reported	Not reported	Not reported

Serum IL-15 on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	31.06	13.55	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	33.89	16.32	Not reported	Not reported	Not reported

Serum IL-15 on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	35.27	19.66	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	43.43	37.40	Not reported	Not reported	Not reported

Serum IL-15 on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	18.73	9.77	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	25.22	15.38	Not reported	Not reported	Not reported

Serum IL-15 on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	10.30	5.90	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	12.92	8.28	Not reported	Not reported	Not reported

Serum IL-15 on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	4.98	3.52	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	7.41	5.21	Not reported	Not reported	Not reported

Serum TNF Alpha on Baseline

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	7.26	7.87	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	6.73	7.86	Not reported	Not reported	Not reported

Serum TNF Alpha on Day 0

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3.32	2.62	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	3.08	1.68	Not reported	Not reported	Not reported

Serum TNF Alpha on Day 3

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	27

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3.95	2.68	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	4.90	4.59	Not reported	Not reported	Not reported

Serum TNF Alpha on Day 7

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3.93	3.10	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	5.97	4.09	Not reported	Not reported	Not reported

Serum TNF Alpha on Week 2

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	26

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.84	6.01	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	2.74	2.30	Not reported	Not reported	Not reported

Serum TNF Alpha on Week 4

Analysis denominator · Participants

Group	Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)	118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	28

Values in pg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2.36	1.65	Not reported	Not reported	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	3.03	2.13	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
339.00
value
466.32
group Id
OG001
spread
539.17
value
634.56
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
28
units
Participants
title
Serum CXCL10 on Baseline
categories
measurements
group Id
OG000
spread
334.85
value
499.16
group Id
OG001
spread
569.42
value
763.99
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
28
units
Participants
title
Serum CXCL10 on Day 0
categories
measurements
group Id
OG000
spread
543.76
value
712.31
group Id
OG001
spread
611.23
value
962.96
denoms
counts
group Id
OG000
value
106
group Id
OG001
value
27
units
Participants
title
Serum CXCL10 on Day 3
categories
measurements
group Id
OG000
spread
572.80
value
841.62
group Id
OG001
spread
563.40
value
1630.98
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
28
units
Participants
title
Serum CXCL10 on Day 7
categories
measurements
group Id
OG000
spread
371.95
value
474.45
group Id
OG001
spread
631.80
value
798.28
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
26
units
Participants
title
Serum CXCL10 on Week 2
categories
measurements
group Id
OG000
spread
535.45
value
623.87
group Id
OG001
spread
640.57
value
964.92
denoms
counts
group Id
OG000
value
118
group Id
OG001
value
28
units
Participants
title
Serum CXCL10 on Week 4
categories
measurements
group Id
OG000
spread
9.68
value
3.58
group Id
OG001
spread
623.76
value
121.49
denoms
counts
group Id
OG000
value
122
group Id
OG001
value
28
units
Participants
title
Serum Granzyme B on Baseline
categories
measurements
group Id
OG000
spread
7.86
value
2.95
group Id
OG001
spread
234.23
value
46.36
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
28
units
Participants
title
Serum Granzyme B on Day 0
categories
measurements
group Id
OG000
spread
11.03
value
6.53
group Id
OG001
spread
348.53
value
74.28
denoms
counts
group Id
OG000
value
106
group Id
OG001
value
27
units
Participants
title
Serum Granzyme B on Day 3
categories
measurements
group Id
OG000
spread
494.66
value
76.29
group Id
OG001
spread
68.63
value
52.87
denoms
counts
group Id
OG000
value
124
group Id
OG001
value
28
units
Participants
title
Serum Granzyme B on Day 7
categories
measurements
group Id
OG000
spread
5.67
value
2.73
group Id
OG001
spread
102.65
value
27.21
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
26
units
Participants
title
Serum Granzyme B on Week 2
categories
measurements
group Id
OG000
spread
5.15
value
3.14
group Id
OG001
spread
39.90
value
17.00
denoms
counts
group Id
OG000
value
118
group Id
OG001
value
28
units
Participants
title
Serum Granzyme B on Week 4

denoms

counts
group Id
OG000
value
124
group Id
OG001
value
28
units
Participants

description

Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha.

dispersion Type

Standard Deviation

groups

description
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG000
title
Axicabtagene Ciloleucel (Follicular Lymphoma)
description
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG001
title
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

param Type

MEAN

population Description

Participants in the Safety Analysis Set with available data were analyzed.

reporting Status

POSTED

time Frame

Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

title

Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha

type

SECONDARY

unit Of Measure

pg/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice