Trial · NCT05537766
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
NCT05537766, Phase 2, Terminated, Kite, A Gilead Company; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies. Trials, record NCT05537766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05537766
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
- NCT number
- NCT05537766
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Kite, A Gilead Company
- Conditions
- Relapsed/Refractory Waldenstrom Macroglobulinemia, Relapsed/Refractory Richter Transformation, Relapsed/Refractory Burkitt Lymphoma, Relapsed/Refractory Hairy Cell Leukemia
- Interventions
- Brexucabtagene Autoleucel, Cyclophosphamide, Fludarabine
- First posted
- 2022-09-13
- Last updated
- 2026-03-10
- Results first posted
- 2026-03-10
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Up to 2 years | 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. |
| Primary | Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification | Up to 2 years | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. |
| Primary | Substudy C: ORR Determined by Central Assessment Per the Lugano Classification | Up to 2 years | ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification. |
| Primary | Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues | Up to 2 years | 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. |
| Secondary | All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment | Up to 2 years | CR Rate is defined as the percentage of participants with CR. |
| Secondary | All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | Up to 2 years | 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. |
| Secondary | All Substudies (Substudies A, B, C and D): Overall Survival (OS) | Up to 2 years | OS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of death from any cause. |
| Secondary | All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | Up to 2 years | 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. |
| Secondary | All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT) | Up to 2 years | 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. |
| Secondary | All Substudies (Substudies A, B, C and D): Time to First Objective Response | Up to 2 years | 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). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Up to 2 years | Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available. | ||
| PRIMARY | Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification | Up to 2 years | 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. | ||
| PRIMARY | Substudy C: ORR Determined by Central Assessment Per the Lugano Classification | Up to 2 years | 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. | ||
| PRIMARY | Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues | Up to 2 years | 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. | ||
| SECONDARY | All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment | Up to 2 years | 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. | ||
| SECONDARY | All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | Up to 2 years | 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. | months | MEDIAN |
| SECONDARY | All Substudies (Substudies A, B, C and D): Overall Survival (OS) | Up to 2 years | 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. | months | MEDIAN |
| SECONDARY | All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | Up to 2 years | 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. | months | MEDIAN |
| SECONDARY | All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT) | Up to 2 years | 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. | months | MEDIAN |
| SECONDARY | All Substudies (Substudies A, B, C and D): Time to First Objective Response | Up to 2 years | 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. | days | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group874
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | NA | 95% Confidence Interval 4.6 to NA | months | |
| All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 5.0 | 95% Confidence Interval 2.2 to NA | months | |
| All Substudies (Substudies A, B, C and D): Duration of Response (DOR) | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 11.3 | 95% Confidence Interval NA to NA | months | |
| All Substudies (Substudies A, B, C and D): Overall Survival (OS) | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 9.6 | 95% Confidence Interval 0.7 to NA | months | |
| All Substudies (Substudies A, B, C and D): Overall Survival (OS) | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 12.9 | 95% Confidence Interval 3.8 to NA | months | |
| All Substudies (Substudies A, B, C and D): Overall Survival (OS) | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 12.1 | 95% Confidence Interval NA to NA | months | |
| All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3.5 | 95% Confidence Interval 0.7 to NA | months | |
| All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 5.8 | 95% Confidence Interval 3.1 to NA | months | |
| All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS) | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 12.1 | 95% Confidence Interval NA to NA | months | |
| All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT) | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 9.6 | 95% Confidence Interval 0.7 to NA | months |
1 to 10 of 874Source ClinicalTrials.gov
See all 874 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 | |
| Overall Study | STARTED | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 6 | |
| Overall Study | STARTED | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 12 | |
| Overall Study | STARTED | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | |
| Overall Study | COMPLETED | Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 | |
| Overall Study | COMPLETED | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 0 | |
| Overall Study | COMPLETED | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 0 | |
| Overall Study | COMPLETED | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 0 | |
| Overall Study | NOT COMPLETED | Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 | |
| Overall Study | NOT COMPLETED | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events429
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | 1 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 0 | 4 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 0 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | 1 | |
| other | Hypofibrinogenaemia | Blood and lymphatic system disorders | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 0 | 4 | |
| other | Hypofibrinogenaemia | Blood and lymphatic system disorders | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 1 | 10 | |
| other | Hypofibrinogenaemia | Blood and lymphatic system disorders | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 0 | 1 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 | 4 |
1 to 10 of 429Source ClinicalTrials.gov
See all 429 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3 | 6 |
| Total, all-cause mortality | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 5 | 12 |
| Total, all-cause mortality | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 0 | 1 |
| Total, other adverse events | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 | 4 |
| Total, other adverse events | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 | 10 |
| Total, other adverse events | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | 1 |
| Total, serious adverse events | Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3 | 4 |
| Total, serious adverse events | Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 6 | 10 |
| Total, serious adverse events | Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05537766
GET https://conductscience.org/api/trials/v1/NCT05537766/registered?page=2