The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.
Combining sonrotoclax (a next-generation BCL-2 inhibitor) with zanubrutinib (a selective BTK inhibitor) in mantle cell lymphoma (MCL)-is expected to be driven by strong biologic synergy, complementary mechanisms, and more durable responses without chemotherapy. Patients participating in this study must already be planning, and be eligible for CAR-T cell therapy outside of this protocol. CAR-T will be administered according to local or provincial guidelines. If a patient decides to take part in this study, the patient will first get zanubrutinib (if not on it before starting the study), then during the induction phase they will get a combination of sonrotoclax (with a ramp-up dosing schedule) plus zanubrutinib followed by CAR-T cell therapy, followed zanubrutinib alone/ maintenance. After finishing study treatment, and even if patients stop treatment early, the study doctor will continue to follow the patient's condition for the rest of their life or until all study results are known
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
assigned at enrollment
assigned at enrollment
Standard of Care
BCCA - Vancouver
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITINGComplete response post CAR-T
Time frame: 3.5 years
Objective Response Rate assessed by the Lugano Classification
Time frame: 3.5 years
1 year Progression-Free Survival
Time frame: 4 years
Overall Survival
Time frame: 4 years
Number and Severity of Adverse Events
Time frame: 3.5 years
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