Clinical Trials

Inclusion Criteria:

- Confirmed MCL diagnosis

- Previously treated with at least one prior line of systemic therapy for MCL

- Measurable disease per Lugano criteria

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor
support within 7 days of screening

- Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days
of screening

- Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7
days of screening.

- AST and ALT ≤ 3.0 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 x ULN.

- Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Exclusion Criteria:

- Prior treatment with an approved or investigational BTK inhibitor

- History of bleeding diathesis

- History of stroke or intracranial hemorrhage within 6 months of randomization

- History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen
receptor modified T-cell (CAR-T) therapy within 60 days of randomization

- Clinically significant cardiovascular disease

- Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3
consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs

- Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with
controlled HBV infections may still be eligible)

- Clinically significant active malabsorption syndrome or other condition likely to
affect gastrointestinal (GI) absorption

- Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or
inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy
prior to start of study drug treatment.

- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K
antagonist.

- Vaccination with live vaccine within 28 days prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/1/23. Questions regarding updates should be directed to the study team contact.