About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy
Eligible for and planned to receive Health Canada approved CAR-T.
Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.
Presence of radiologically documented disease.
Disqualifiers
• Participants on active anticancer therapy for other advanced or metastatic malignancies.
Concurrent treatment with other anti-cancer therapy
Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.
Known hypersensitivity to the study drug(s) or their components.
Trial design
Single group
Treatments tested in this trial
Zanubrutinib
Drugassigned at enrollment
Sonrotoclax
Drugassigned at enrollment
CAR-T Cell Therapy
Biological/VaccineStandard of Care
Treatment groups
Trial outcomes
Primary outcomes
Complete response post CAR-T
Secondary outcomes
Objective Response Rate assessed by the Lugano Classification
1 year Progression-Free Survival
Overall Survival
Number and Severity of Adverse Events
Sponsors and contacts
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Canadian Cancer Trials Group
Lead sponsor
BeOne Medicines
Collaborator