Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned f… (NCT07341191) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
40 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* Measurable disease (one site bidimensionally measurable).
* Age ≥ 18 years.
* Have an ECOG performance status of 0, 1 or 2
* Anticipated life expectancy of ≥ 6 months
* Adequate hematologic and biochemical parameters
* Must have received prior systemic therapy as shown below;
* At least one line of systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi).
* Participants who have previously received venetoclax, sonrotoclax, or any other BCL2 inhibitor (BCL2i) are eligible as long as progressive disease did not occur within 6 months of the last dose of BCL2i. Participants with progressive disease during BCL2i therapy or within 6 months of last dose are not eligible.
* Participants must enter the study while on a BTKi or enroll to a substudy of the protocol to receive zanubrutinib for a minimum duration prior to enrolling to the main study.
* Participants previously exposed to zanubrutinib are eligible irrespective of response to treatment.
* Participants entering the study while on a BTKi must have their BTKi switched to zanubrutinib supplied through the s…