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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501259-10 | Other Identifier | European Medicines Agency | |
| 2022-501260-18 | Other Identifier | European Medicines Agency | |
| 2022-501261-46 | Other Identifier | European Medicines Agency | |
| 2022-501262-21 | Other Identifier | European Medicines Agency |
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Sponsor decision to terminate study.
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Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).
This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL.
After completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.
All substudies have been early terminated by the sponsor. Below is summary of enrollment in each Substudy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | Experimental | Participants with Relapsed/Refractory Waldenstrom Macroglobulinemia will receive the following treatment during the study:Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day intravenously (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-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg on Day 0. |
|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | Experimental | Participants with Relapsed/Refractory Richter Transformation will receive 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 | Experimental | Participants with Relapsed/Refractory Burkitt Lymphoma will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexucabtagene Autoleucel | Biological | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment Per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM) | The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR per the Sixth International Workshop in WM. | Up to 2 years |
| Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. | Up to 2 years |
| Substudy C: ORR Determined by Central Assessment Per the Lugano Classification | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. | Up to 2 years |
| Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets >100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment | CR Rate is defined as the percentage of participants with CR. | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Duration of Response (DOR) |
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Key Inclusion Criteria:
All Substudies:
Substudy B:
Confirmed diagnosis of chronic lymphocytic leukemia (CLL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria with histologically confirmed Richter transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype.
Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:
At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Substudy C:
Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia.
Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:
At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
Key Exclusion Criteria:
All Substudies:
Substudy B:
Substudy C:
Substudies A and D have been early terminated by the sponsor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center) | Duarte | California | 91010 | United States | ||
| Stanford Cancer Institute |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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29 participants were screened (Substudy A:1; Substudy B: 10; Substudy C: 16; Substudy D: 2). Substudy A was withdrawn, prior to enrollment of any participants. Therefore, the results below are reported only for Substudies B, C, and D.
Participants were enrolled at study sites in Netherlands, Italy, Germany, Switzerland, Spain, and the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | This substudy was withdrawn; therefore, no participants were enrolled. |
| FG001 | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: KT-US-568-0138 (ZUMA-25) - Master Protocol | Aug 17, 2023 |
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| Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel | Experimental | Participant with Relapsed/Refractory Hairy Cell Leukemia will receive 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. |
|
|
| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: score 4 (uptake moderately >liver) or 5 (uptake markedly>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. |
| Up to 2 years |
| All Substudies (Substudies A, B, C and D): Overall Survival (OS) | OS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of death from any cause. | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6. | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT) | TTNT defined as the time from the date of brexucabtagene autoleucel infusion to the start of new anti-cancer (including stem cell transplant) therapy prior to documented progression, or death from any cause. KM estimates were used in the outcome measure analysis. | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Time to First Objective Response | Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Time to Best Objective Response | Time to best objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of best response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as any adverse event with onset on or after the brexucabtagene autoleucel infusion. | First infusion date of brexucabtagene autoleucel up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | 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. | First infusion date of brexucabtagene autoleucel up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized. | First dose date up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) | Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion. | First infusion date of brexucabtagene autoleucel up to 28 days |
| All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants With Replication-competent Retrovirus (RCR) in Peripheral Blood Mononuclear Cells (PBMCs) | Up to 2 years |
| All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. Participants with deterioration scores from screening for various questions of EORTC QLQ C-30 are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline. | Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
| All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) | EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants with deterioration scores from screening for each category are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline. | Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
| All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score | The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine". | Screening, Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
| Substudy A: ORR (CR, VGPR, or PR) Determined by Central Assessment Per the Sixth International Workshop in WM | ORR was defined as the percentage of participants who achieved a best response of CR, VGPR, or PR per the Sixth International Workshop in WM. | Up to 2 years |
| Substudy A: Percentage of Participants With Combined CR and VGPR Determined by Investigator Assessment Per the Sixth International Workshop in WM | The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR. | Up to 2 years |
| Substudy A: PR Rate Determined by Central Assessment Per the Sixth International Workshop in WM | PR rate was defined as percentage of participants who achieve PR. | Up to 2 years |
| Substudy A: VGPR Rate Determined by Central Assessment Per the Sixth International Workshop in WM | VGPR rate was defined as percentage of participants who achieve VGPR. | Up to 2 years |
| Substudy B: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification | OR: CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR)+partial RR(PRR)). CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment. PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/ normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal. | Up to 2 years |
| Substudy B: Number of Participants With OR Based on Clonal Relationship to the Underlying CLL by Central Assessment Per the Lugano Classification | OR is defined as participants with CR or PR. | Up to 2 years |
| Substudy B: Number of Participants With OR (CR, CRi, or PR) Determined by Investigator Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 Criteria | OR was defined as the number of participants who achieved a best response of either CR, CRi, or PR by investigator assessment per IWCLL 2018 criteria. CR: Lymph nodes- none ≥1.5 cm; Liver or spleen size- Spleen size <13 cm; liver size normal; Constitutional symptoms, Circulating lymphocyte count- none; Platelet count- ≥100 × 109/L; Hemoglobin- ≥11.0 g/dL (untransfused and without erythropoietin); Marrow- Normocellular, no CLL cells, no B-lymphoid nodules. CRi: ; PR: Lymph nodes- Decrease ≥50% (from baseline); Liver or spleen size- Decrease ≥50% (from baseline); Constitutional symptoms- any, Circulating lymphocyte count- Decrease ≥50% from baseline; Platelet count- ≥100 × 109/L or increase ≥50% over baseline; Hemoglobin-≥11 g/dL or increase ≥50% over baseline; Marrow- Presence of CLL cells, or of B-lymphoid nodules, or not done. | Up to 2 years |
| Substudy C: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification | OR was defined as the number of participants who achieved a best response of either CR or PR per the Lugano Classification. CR and PR per Lugano classification is defined in outcome measure #25. | Up to 2 years |
| Substudy D: Number of Participants With OR Determined by Investigator Assessment Per Grever and Colleagues | OR was defined as the number of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets>100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL. | Up to 2 years |
| Stanford |
| California |
| 94305 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Georgetown University Medical Centre | Washington D.C. | District of Columbia | 20037 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Ohio State University Wexner Medical Center - James Cancer HospitalS | Columbus | Ohio | 43210 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical University of Vienna, Department of Internal Medicine I, Div. of Hematology | Vienna | 01090 | Austria |
| Hopital de la Pitie Salpetriere | Paris | 75013 | France |
| Centre hospitalier de Toulouse - Hematology department | Toulouse | 31059 | France |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| IRCCS Azienda Ospedaliero - Universitaria di Bologna | Bologna | 40138 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Azienda Ospedale di Perugia - Ospedale S. Maria della Misericordia | Perugia | 06132 | Italy |
| Radboud University Nijmegen Medical Centre | Nijmegen | 6525 GA | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Istituto Oncologico Della Svizzera Italiana (IOSI) | Bellinzona | 6500 | Switzerland |
Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day intravenously (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-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg on Day 0. |
| FG002 | 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 intravenously (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. |
| FG003 | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | Participant with Relapsed/Refractory Hairy Cell Leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day intravenously (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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | This substudy was withdrawn; therefore, no participants were enrolled. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment Per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM) | The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR per the Sixth International Workshop in WM. | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Up to 2 years |
|
| |||||||||||||||||||
| Primary | Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. | Data cannot be reported for this outcome measure because substudy B was terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future. | Posted | Up to 2 years |
|
| |||||||||||||||||||
| Primary | Substudy C: ORR Determined by Central Assessment Per the Lugano Classification | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. | Data cannot be reported for this outcome measure because substudy C was terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future. | Posted | Up to 2 years |
|
| |||||||||||||||||||
| Primary | Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets >100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL. | Data cannot be reported for this outcome measure because substudy D was terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future. | Posted | Up to 2 years |
|
| |||||||||||||||||||
| Secondary | All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment | CR Rate is defined as the percentage of participants with CR. | Data cannot be reported for this outcome measure because all substudies were terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future. | Posted | Up to 2 years |
| ||||||||||||||||||||
| Secondary | All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: score 4 (uptake moderately >liver) or 5 (uptake markedly>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. | The Modified Intent-to-Treat Analysis Set consisted of all participants enrolled and treated with pivotal dose of brexucabtagene autoleucel, with measurable disease at baseline (or post-bridging therapy, if applicable). Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set with objective response were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| |||||||||||||||||
| Secondary | All Substudies (Substudies A, B, C and D): Overall Survival (OS) | OS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of death from any cause. | Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6. | Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT) | TTNT defined as the time from the date of brexucabtagene autoleucel infusion to the start of new anti-cancer (including stem cell transplant) therapy prior to documented progression, or death from any cause. KM estimates were used in the outcome measure analysis. | Participants in substudies B and C, in the Modified Intent-to-Treat Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. Substudy D : No participants received next therapy, so no data were reported. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Time to First Objective Response | Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). | Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set with objective response were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Mean | Standard Deviation | days | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Time to Best Objective Response | Time to best objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of best response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). | Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set with objective response were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Mean | Standard Deviation | days | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | TEAE was defined as any adverse event with onset on or after the brexucabtagene autoleucel infusion. | 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. | Posted | Count of Participants | Participants | No | First infusion date of brexucabtagene autoleucel up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | 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. | 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. | Posted | Count of Participants | Participants | No | First infusion date of brexucabtagene autoleucel up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized. | 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. | Posted | Count of Participants | Participants | No | First dose date up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) | Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion. | Participants in Substudies B, C, and D in DLT Evaluable Set were analyzed. DLT Evaluable Set consisted of first 3 participants treated. When 1 of these participants experienced a DLT within 28 days post-brexucabtagene autoleucel infusion, 3 more participants were added. This resulted in more than 3 DLT evaluable participants in Substudies B & C, and only 1 extra participant enrolled in Substudy B due to early study termination. Substudy A was withdrawn before enrollment, so no data is available. | Posted | Count of Participants | Participants | No | First infusion date of brexucabtagene autoleucel up to 28 days |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies | 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. | Posted | Count of Participants | Participants | No | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Replication-competent Retrovirus (RCR) in Peripheral Blood Mononuclear Cells (PBMCs) | Participants in substudies B, C and D, in the Safety Analysis Set were analyzed. Substudy A was terminated prematurely, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Count of Participants | Participants | No | Up to 2 years |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. Participants with deterioration scores from screening for various questions of EORTC QLQ C-30 are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline. | Participants in substudies B, C and D, in the Safety Analysis Set with available data were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Count of Participants | Participants | No | Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) | EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants with deterioration scores from screening for each category are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline. | Participants in substudies B, C and D, in the Safety Analysis Set with available data were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Count of Participants | Participants | No | Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score | The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine". | Participants in substudies B, C and D, in the Safety Analysis Set with available data were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Mean | Standard Deviation | score on scale | Screening, Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | Substudy A: ORR (CR, VGPR, or PR) Determined by Central Assessment Per the Sixth International Workshop in WM | ORR was defined as the percentage of participants who achieved a best response of CR, VGPR, or PR per the Sixth International Workshop in WM. | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Up to 2 years |
|
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| Secondary | Substudy A: Percentage of Participants With Combined CR and VGPR Determined by Investigator Assessment Per the Sixth International Workshop in WM | The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR. | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Up to 2 years |
|
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| Secondary | Substudy A: PR Rate Determined by Central Assessment Per the Sixth International Workshop in WM | PR rate was defined as percentage of participants who achieve PR. | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Up to 2 years |
|
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| Secondary | Substudy A: VGPR Rate Determined by Central Assessment Per the Sixth International Workshop in WM | VGPR rate was defined as percentage of participants who achieve VGPR. | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | Posted | Up to 2 years |
|
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| Secondary | Substudy B: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification | OR: CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR)+partial RR(PRR)). CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment. PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/ normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal. | Participants in substudy B, in the Modified Intent-to-Treat Analysis Set were analyzed. | Posted | Count of Participants | Participants | No | Up to 2 years |
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| Secondary | Substudy B: Number of Participants With OR Based on Clonal Relationship to the Underlying CLL by Central Assessment Per the Lugano Classification | OR is defined as participants with CR or PR. | Data not available since Substudy B was terminated early and central committee was not formed and central assessment was not conducted, therefore, data is not available for this outcome measure. | Posted | Up to 2 years |
|
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| Secondary | Substudy B: Number of Participants With OR (CR, CRi, or PR) Determined by Investigator Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 Criteria | OR was defined as the number of participants who achieved a best response of either CR, CRi, or PR by investigator assessment per IWCLL 2018 criteria. CR: Lymph nodes- none ≥1.5 cm; Liver or spleen size- Spleen size <13 cm; liver size normal; Constitutional symptoms, Circulating lymphocyte count- none; Platelet count- ≥100 × 109/L; Hemoglobin- ≥11.0 g/dL (untransfused and without erythropoietin); Marrow- Normocellular, no CLL cells, no B-lymphoid nodules. CRi: ; PR: Lymph nodes- Decrease ≥50% (from baseline); Liver or spleen size- Decrease ≥50% (from baseline); Constitutional symptoms- any, Circulating lymphocyte count- Decrease ≥50% from baseline; Platelet count- ≥100 × 109/L or increase ≥50% over baseline; Hemoglobin-≥11 g/dL or increase ≥50% over baseline; Marrow- Presence of CLL cells, or of B-lymphoid nodules, or not done. | Participants in substudy B, in the Modified Intent-to-Treat Analysis Set were analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Substudy C: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification | OR was defined as the number of participants who achieved a best response of either CR or PR per the Lugano Classification. CR and PR per Lugano classification is defined in outcome measure #25. | Participants in substudy C, in the Modified Intent-to-Treat Analysis Set were analyzed. | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Substudy D: Number of Participants With OR Determined by Investigator Assessment Per Grever and Colleagues | OR was defined as the number of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets>100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL. | Participants in substudy D, in the Modified Intent-to-Treat Analysis Set were analyzed. | Posted | Count of Participants | Participants | No | Up to 2 years |
|
|
Up to 2 years
All-cause mortality: The full analysis set included all enrolled participants (the participants who had leukapheresis) Adverse Events: The safety analysis set is defined as all participants treated with any dose of brexucabtagene autoleucel.
As no participants were enrolled in Substudy A and no dose was received, data for adverse events is reported only for Substudies B, C, and D.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 intravenously (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-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg IV on Day 0. | 3 | 6 | 3 | 4 | 4 | 4 |
| EG001 | 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 intravenously (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 IV on Day 0. | 5 | 12 | 6 | 10 | 10 | 10 |
| EG002 | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | Participant with Relapsed/Refractory Hairy Cell Leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day intravenously (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 IV on Day 0. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolysis | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle mass | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Apraxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Allergy to immunoglobulin therapy | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral haemorrhagic cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspergillus test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Apraxia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sensitive skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Dec 16, 2025 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: KT-US-568-0138-A (ZUMA-25A)- Amendment 2 | Mar 1, 2023 | Dec 16, 2025 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: KT-US-568-0138-B (ZUMA-25B) Amendment 3 | Aug 17, 2023 | Dec 16, 2025 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: KT-US-568-0138-C (ZUMA-25C) Amendment 3 | Aug 17, 2023 | Dec 16, 2025 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: KT-US-568-0138-D (ZUMA-25D) Amendment 2 | Mar 1, 2023 | Dec 16, 2025 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2023 | Jan 22, 2026 | SAP_005.pdf |
Not provided
| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| D007943 | Leukemia, Hairy Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D007938 | Leukemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705347 | brexucabtagene autoleucel |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Italy |
|
| Switzerland |
|
| Germany |
|
| Spain |
|
| Participants |
|
| OG003 | 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. |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
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.
| OG003 | 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. |
|
|
| 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. |
| OG003 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
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.
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
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