Phase 2 Study of Mosunetuzumab and Zanubrutinib for Patients with Returning or Hard-to-Treat Marginal Zone Lymphoma

Inclusion Criteria

• Diagnosed with marginal zone lymphoma (MZL) or low-grade lymphoma.
• Have received at least one prior treatment, including a CD20 monoclonal antibody.
• Cancer is at stage II, III, or IV.
• Aged 18 years or older.
• Have a performance status score of 2 or less on the ECOG scale (or 3 if due to lymphoma).
• Require systemic therapy based on tumor size, symptoms, or specific criteria.
• Have a tumor mass larger than 7 cm or multiple sites larger than 3 cm.
• Experience at least one B symptom, such as fever, night sweats, or significant weight loss.
• Have symptomatic spleen enlargement or risk of organ compression.
• Have certain blood count levels due to bone marrow involvement.
• Have measurable disease by scans.
• Have adequate organ and marrow function as defined by specific blood tests.
• Understand the potential risks of the study drug and agree to certain conditions, such as not donating blood or sharing medication.
• Women must not be pregnant or breastfeeding and must use effective contraception.
• Men must use a barrier method of birth control and not donate sperm during and after treatment.
• Agree to sign an informed consent document and understand the study procedures.

Exclusion Criteria

• Have active central nervous system lymphoma or leptomeningeal disease.
• Have received any chemotherapy or anti-lymphoma treatment within 4 weeks before starting the study.
• Have a history of other cancers unless disease-free for 3 years, except for certain skin or cervical cancers.
• Have uncontrolled HIV, Hepatitis C, or active Hepatitis B infection.
• Have a history of immunodeficiency or are on systemic immunosuppressant therapy.
• Require chronic treatment with strong CYP3A inhibitors unless discontinued or adjusted.
• Have significant heart disease or recent heart attack.
• Have active bleeding disorders or recent stroke.
• Are pregnant or breastfeeding.
• Have had major surgery within 28 days or minor surgery within 3 days of starting the study.
• Have a history of chronic active Epstein-Barr virus infection.
• Have received a live vaccine within 4 weeks before starting the study.
• Have had a solid organ or allogeneic stem cell transplant.
• Have difficulty swallowing or gastrointestinal issues affecting medication absorption.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of pneumonitis requiring steroids or current pneumonitis.