Brexucabtagene Autoleucel

BIOLOGICAL11 trials

Sponsors

Kite, A Gilead Company, M.D. Anderson Cancer Center, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt-Ingram Cancer Center, University of Michigan Rogel Cancer Center

Conditions

Acute Lymphoblastic LeukemiaAutoimmune DiseasesLymphomaMantle Cell LymphomaNon-hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Mantle Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma

Early Phase 1

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

Active, not recruitingNCT05495464

M.D. Anderson Cancer CenterLymphoma, Mantle Cell Lymphoma

Start: 2022-11-18End: 2027-03-31Updated: 2026-08-12

Phase 1

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

CompletedNCT02614066

Kite, A Gilead CompanyRelapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Start: 2016-03-07End: 2023-11-03Updated: 2024-11-19

Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

TerminatedNCT03624036

Kite, A Gilead CompanyRelapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma

Start: 2018-11-15End: 2022-11-18Updated: 2023-11-18

Phase 2

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

CompletedNCT02601313

Kite, A Gilead CompanyRelapsed/Refractory Mantle Cell Lymphoma

Start: 2015-11-09End: 2023-09-22Updated: 2026-03-18

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)

CompletedNCT04880434

Kite, A Gilead CompanyRelapsed/Refractory Mantle Cell Lymphoma

Start: 2021-04-23End: 2025-06-17Updated: 2026-08-18

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

TerminatedNCT05537766

Kite, A Gilead CompanyRelapsed/Refractory Burkitt Lymphoma, Relapsed/Refractory Hairy Cell Leukemia, Relapsed/Refractory Richter Transformation +1

Start: 2022-11-01End: 2025-01-27Updated: 2026-03-10

Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

RecruitingNCT06553872

H. Lee Moffitt Cancer Center and Research InstituteMantle Cell Lymphoma

Start: 2024-08-23End: 2029-08-01Target: 60Updated: 2026-09-23

Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma

RecruitingNCT07763210

Vanderbilt-Ingram Cancer CenterNon-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma +2

Start: 2026-09-25End: 2029-10-01Target: 59Updated: 2026-10-02

Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy

RecruitingNCT07892027

University of Michigan Rogel Cancer CenterRecurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma +1

Start: 2026-11-01End: 2028-05-01Target: 26Updated: 2026-10-23

Unknown Phase

Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies

Enrolling by invitationNCT05041309

Kite, A Gilead CompanyAutoimmune Diseases, Solid and Hematological Malignancies

Start: 2021-12-15End: 2040-12-01Target: 1500Updated: 2026-09-21

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Kite, A Gilead CompanyAcute Lymphoblastic Leukemia, Mantle Cell Lymphoma

Updated: 2026-04-08

Related Papers

Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2

Journal of Hematology & Oncology2026-04-27

Ibrutinib exposure correlates with improved efficacy of CAR T cells in patients with mantle cell lymphoma

Blood Advances2026-02-11

Two-year update of ZUMA-2 Cohort 3: Brexucabtagene autoleucel (Brexu-cel) in patients (pts) with relapsed/refractory mantle cell lymphoma (R/R MCL) who had not received prior Bruton tyrosine kinase inhibitor (BTKi) therapy

Blood2025-11-03

Acalabrutinib plus rituximab followed by brexucabtagene autoleucel for frontline treatment of high-risk Mantle Cell Lymphoma: The window-3 clinical trial

Blood2025-11-03

ZUMA-25 preliminary analysis: A Phase 2 study of brexucabtagene autoleucel (brexu-cel) in patients (Pts) with relapsed/refractory (R/R) burkitt lymphoma (BL), substudy C

Blood2025-11-03

Endogenous regulation of inflammatory response as a determinant of durable remission without stem cell transplant following brexucabtagene autoleucel (Brexu-cel) therapy in ALL

Blood2025-11-03

Brexucabtagene autoleucel for BTKi-naive relapsed/refractory mantle cell lymphoma: primary analysis of ZUMA-2 Cohort 3.

2025-10-29

ZUMA-8: a phase 1 study of brexucabtagene autoleucel in patients with relapsed/refractory chronic lymphocytic leukemia

Blood2025-04-105 citations

Five-Year Outcomes of Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated with Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 Cohorts 1 and 2

Blood2024-11-056 citations

Primary Analysis of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Were Naive to Bruton Tyrosine Kinase Inhibitors (BTKi)

Blood2024-11-055 citations

Long-term survival outcomes of patients (pts) with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-3.

Journal of Clinical Oncology2024-06-013 citations

Prognostic Insights for Relapsed/Refractory Mantle Cell Lymphoma

Oncology Times2023-11-05

Matching-Adjusted Indirect Comparison (MAIC) of Brexucabtagene Autoleucel (Brexu-cel) and Pirtobrutinib in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (cBTKi)

Blood2023-11-021 citations

Impact of age, prior therapies, and subsequent transplant on long-term outcomes of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with brexucabtagene autoleucel (brexu-cel) in ZUMA-3.

Journal of Clinical Oncology2023-06-013 citations

Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study.

2022-12-1054 citations

ZUMA-8: A Phase 1 Study of KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

Blood2022-11-1511 citations

Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States.

2022-06-219 citations

Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients (Pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) in ZUMA-3.

Journal of Clinical Oncology2022-06-019 citations

Three-year follow-up of outcomes with KTE-X19 in patients with relapsed/refractory mantle cell lymphoma in ZUMA-2.

Journal of Clinical Oncology2022-06-016 citations

Cost-effectiveness analysis of KTE-X19 CAR T therapy versus real-world standard of care in patients with relapsed/refractory mantle cell lymphoma post BTKi in England.

2022-01-016 citations

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