Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
NCT ID: NCT05537766
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2022-11-01
2025-01-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT02614066
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
NCT02625480
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT01466179
Blinatumomab Bridging Therapy for BALL
NCT04556084
A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies
NCT02223598
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Substudies A and D have been early terminated by the sponsor.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg.
This arm is no longer recruiting.
Brexucabtagene Autoleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2×10\^6 anti-CD19 CAR T cells/kg.
This arm is no longer recruiting.
Brexucabtagene Autoleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2x10\^6 anti-CD19 CAR T cells/kg.
Brexucabtagene Autoleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
Participants will receive fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg.
This arm is no longer recruiting.
Brexucabtagene Autoleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brexucabtagene Autoleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate hematologic and end-organ function.
* Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
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:
* Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy.
* Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
* 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:
* Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded.
* Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
* 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.
Exclusion Criteria
* Prior CAR therapy or treatment with any anti-CD19 therapy.
* HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count \> 200 cells/uL.
* Presence of detectable cerebrospinal fluid malignant cells or brain metastases.
* History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus).
Substudy B:
* Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma (HL) and prolymphocytic leukemia).
* Prior allogeneic or autologous stem cell transplant \< 3 months prior to screening and/or \< 4 months prior to planned infusion of brexucabtagene autoleucel.
* Presence of active graft-versus-host disease following prior stem cell transplant.
Substudy C:
* Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified.
* Prior allogeneic stem cell transplant \< 3 months prior to screening and/or \< 4 months prior to planned infusion of brexucabtagene autoleucel.
* Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.
* Presence of CNS involvement. Individuals with a prior history of CNS involvement are eligible if they show a negative CSF and no involvement by imaging.
Substudies A and D have been early terminated by the sponsor.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kite, A Gilead Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope (City of Hope National Medical Center)
Duarte, California, United States
Stanford Cancer Institute
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Georgetown University Medical Centre
Washington D.C., District of Columbia, United States
University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Ohio State University Wexner Medical Center - James Cancer HospitalS
Columbus, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical University of Vienna, Department of Internal Medicine I, Div. of Hematology
Vienna, , Austria
Hopital de la Pitie Salpetriere
Paris, , France
Centre hospitalier de Toulouse - Hematology department
Toulouse, , France
Universitatsklinikum Koln
Cologne, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedale di Perugia - Ospedale S. Maria della Misericordia
Perugia, , Italy
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Istituto Oncologico Della Svizzera Italiana (IOSI)
Bellinzona, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-501259-10
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501260-18
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501261-46
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501262-21
Identifier Type: OTHER
Identifier Source: secondary_id
KT-US-568-0138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.