NCT02601313 · OUTCOME
Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- pg/mL
- Interval / dispersion
- Full Range
- Time frame
- Baseline up to Week 4
What was measured
Peak was defined as the maximum post-baseline level of the cytokine.
Analysis population: Participants in the Safety Analysis Set were analyzed.
Groups in this outcome
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 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 |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 68 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 14 |
|---|
Reported measurements
CXCL10
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 2000.00 | Not reported | 256.60 | 2000.00 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 2000.00 | Not reported | 495.80 | 2000.00 | Not reported |
|---|
Granzyme B
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 40.60 | Not reported | 1.00 | 6024.40 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 24.60 | Not reported | 1.00 | 231.70 | Not reported |
|---|
IFN-gamma
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 410.25 | Not reported | 7.50 | 1876.00 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 442.75 | Not reported | 7.50 | 1876.00 | Not reported |
|---|
IL-1 RA
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 1782.65 | Not reported | 158.40 | 9000.00 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 1783.05 | Not reported | 639.20 | 5012.20 | Not reported |
|---|
IL-2
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 5.85 | Not reported | 0.90 | 77.60 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 6.70 | Not reported | 0.90 | 21.50 | Not reported |
|---|
IL-6
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 86.00 | Not reported | 1.60 | 976.00 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 50.70 | Not reported | 3.20 | 976.00 | Not reported |
|---|
IL-7
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 32.20 | Not reported | 16.30 | 72.80 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 31.80 | Not reported | 13.50 | 81.30 | Not reported |
|---|
IL-8
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 41.19 | Not reported | 9.60 | 750.00 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 53.20 | Not reported | 10.60 | 140.70 | Not reported |
|---|
IL-10
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 16.55 | Not reported | 0.70 | 246.10 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 246.10 | Not reported | 3.40 | 349.30 | Not reported |
|---|
IL-15
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 40.30 | Not reported | 13.70 | 188.70 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 35.60 | Not reported | 27.10 | 80.90 | Not reported |
|---|
TNF alpha
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 9.50 | Not reported | 2.00 | 116.57 | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 10.85 | Not reported | 2.60 | 62.50 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 256.60
- upper Limit
- 2000.00
- value
- 2000.00
- group Id
- OG001
- lower Limit
- 495.80
- upper Limit
- 2000.00
- value
- 2000.00
- title
- CXCL10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 6024.40
- value
- 40.60
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 231.70
- value
- 24.60
- title
- Granzyme B
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.50
- upper Limit
- 1876.00
- value
- 410.25
- group Id
- OG001
- lower Limit
- 7.50
- upper Limit
- 1876.00
- value
- 442.75
- title
- IFN-gamma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 158.40
- upper Limit
- 9000.00
- value
- 1782.65
- group Id
- OG001
- lower Limit
- 639.20
- upper Limit
- 5012.20
- value
- 1783.05
- title
- IL-1 RA
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.90
- upper Limit
- 77.60
- value
- 5.85
- group Id
- OG001
- lower Limit
- 0.90
- upper Limit
- 21.50
- value
- 6.70
- title
- IL-2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.60
- upper Limit
- 976.00
- value
- 86.00
- group Id
- OG001
- lower Limit
- 3.20
- upper Limit
- 976.00
- value
- 50.70
- title
- IL-6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.30
- upper Limit
- 72.80
- value
- 32.20
- group Id
- OG001
- lower Limit
- 13.50
- upper Limit
- 81.30
- value
- 31.80
- title
- IL-7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.60
- upper Limit
- 750.00
- value
- 41.19
- group Id
- OG001
- lower Limit
- 10.60
- upper Limit
- 140.70
- value
- 53.20
- title
- IL-8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.70
- upper Limit
- 246.10
- value
- 16.55
- group Id
- OG001
- lower Limit
- 3.40
- upper Limit
- 349.30
- value
- 246.10
- title
- IL-10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.70
- upper Limit
- 188.70
- value
- 40.30
- group Id
- OG001
- lower Limit
- 27.10
- upper Limit
- 80.90
- value
- 35.60
- title
- IL-15
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.00
- upper Limit
- 116.57
- value
- 9.50
- group Id
- OG001
- lower Limit
- 2.60
- upper Limit
- 62.50
- value
- 10.85
- title
- TNF alpha
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Peak was defined as the maximum post-baseline level of the cytokine.
- dispersion Type
- Full Range
- groups
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG000
- title
- Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG001
- title
- Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
- param Type
- MEDIAN
- population Description
- Participants in the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline up to Week 4
- title
- Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
- type
- SECONDARY
- unit Of Measure
- pg/mL
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