Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy

Inclusion Criteria19

• 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 study.
• Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
• Adequate washout must be followed per protocol.
• Prior high-dose myelosuppresive radiation is permitted ≥28 prior to enrollment.
• Previous major surgery is permitted ≥28 days prior to enrollment. Participants of childbearing potential must have agreed to use a highly effective contraceptive method.