Experimental CAR T-Cell therapy targets rare B-Cell cancers
NCT ID NCT05537766
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tested a treatment called brexucabtagene autoleucel, a CAR T-cell therapy made from a patient's own immune cells, for four rare B-cell cancers: Waldenstrom macroglobulinemia, Richter transformation, Burkitt lymphoma, and hairy cell leukemia. The trial enrolled 19 adults whose cancers had returned or stopped responding to standard treatments. The study was terminated early, so the full effectiveness and safety are not yet clear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexucabtagene autoleucel (a CAR T-cell therapy made from the patient's own immune cells)
- What this could lead to
- If successful, this could offer a new treatment option for people with rare B-cell cancers that have not responded to standard therapy.
- What could go wrong
- The trial was terminated early with only 19 participants, so results are limited. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and nervous system problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
19 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: All Substudies: * 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. Key Exclusion Criteria: All Substudies: * Prior chimeric antigen receptor (CAR) therapy or treatment with any anti-Cluster of Differentiation 19 (CD19) therapy. * human immunodeficiency virus (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/μL. * 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 central nervous system (CNS) involvement. Individuals with a prior history of CNS involvement are eligible if they show a negative cerebrospinal fluid (CSF) and no involvement by imaging. Substudies A and D have been early terminated by the sponsor. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Relapsed/refractory Burkitt lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
-
Azienda Ospedale di Perugia - Ospedale S. Maria della Misericordia
Perugia, 06132, Italy
-
Centre hospitalier de Toulouse - Hematology department
Toulouse, 31059, France
-
City of Hope (City of Hope National Medical Center)
Duarte, California, 91010, United States
-
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
-
Georgetown University Medical Centre
Washington D.C., District of Columbia, 20037, United States
-
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
-
Hopital de la Pitie Salpetriere
Paris, 75013, France
-
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
-
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
-
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
-
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138, Italy
-
Istituto Oncologico Della Svizzera Italiana (IOSI)
Bellinzona, 6500, Switzerland
-
MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
Medical University of Vienna, Department of Internal Medicine I, Div. of Hematology
Vienna, 01090, Austria
-
Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA, Netherlands
-
Stanford Cancer Institute
Stanford, California, 94305, United States
-
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, 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
-
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
-
Universitatsklinikum Koln
Cologne, 50937, Germany
-
Universitatsklinikum Ulm
Ulm, 89081, Germany
-
University of Iowa
Iowa City, Iowa, 52242, United States
-
Vanderbilt University
Nashville, Tennessee, 37232, United States
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States