All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Source last updated 2026-03-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
First infusion date of brexucabtagene autoleucel up to 2 years
What was measured
Laboratory results were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE grading is a standardized system from the NCI that classifies the severity of side effects (adverse events) from cancer treatments, using a 1-5 scale: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death) The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
Analysis population: Participants in substudies B, C and D, in the Safety Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
Groups in this outcome
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
This substudy was withdrawn; therefore, no participants were enrolled.
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study:
Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR 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
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
0
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
4
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
10
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
1
Reported measurements
Hemoglobin (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Leukocytes (10^9/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Lymphocytes (10^9/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase (U/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
3
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Bilirubin (umol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Glucose (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase (U/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase (U/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Direct Bilirubin (umol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Calcium (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Creatinine (umol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Potassium (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Sodium (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Urate (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
2
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Magnesium (mmol/L)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
1
Not reported
Not reported
Not reported
Not reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
title
Hemoglobin (mmol/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Leukocytes (10^9/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Lymphocytes (10^9/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
0
title
Alanine Aminotransferase (U/L)
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
0
title
Bilirubin (umol/L)
categories
measurements
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
0
title
Glucose (mmol/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Alkaline Phosphatase (U/L)
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
0
title
Aspartate Aminotransferase (U/L)
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
0
title
Direct Bilirubin (umol/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Calcium (mmol/L)
categories
measurements
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
title
Creatinine (umol/L)
categories
measurements
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Potassium (mmol/L)
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
10
group Id
OG003
value
1
units
Participants
description
Laboratory results were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE grading is a standardized system from the NCI that classifies the severity of side effects (adverse events) from cancer treatments, using a 1-5 scale: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death) The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
groups
description
This substudy was withdrawn; therefore, no participants were enrolled.
id
OG000
title
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
description
Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study:
Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
id
OG001
title
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
description
Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
id
OG002
title
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
description
Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion 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 of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
id
OG003
title
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants in substudies B, C and D, in the Safety Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
reporting Status
POSTED
time Frame
First infusion date of brexucabtagene autoleucel up to 2 years
title
All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Triangle