A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

NCT06563505 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-0243NCI-2024-06965
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Treatment w/Mosunetuzumab + Zanubrutinib

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Zanubrutinib

Interventions

Mosunetuzumab DRUG

Given by IV

Also known as: RO7030816

Treatment w/Mosunetuzumab + Zanubrutinib

Zanubrutinib DRUG

Given by IV

Treatment w/Mosunetuzumab + Zanubrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria for study entry:
• Histologically diagnosed marginal zone lymphoma (any subtypes)
• o Low grade or indolent B-cell lymphoma unclassifiable is also eligible
• Have received at least 1 prior treatment including CD20 monoclonal antibody
• Patients have relapsed or refractory disease to their most recent regimen
• Stage II, III or IV disease
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of mosunetuzumab and zanubrutinib combination in patients \<18 years of age, children are excluded from this study.
• Performance status ≤2 on the ECOG scale (≤3 if due to lymphoma)
• Requiring systemic therapy assessed by investigator based on tumor size, symptoms and/or GELF criteria
• A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter
• At least 3 nodal or extranodal sites ≥ 3 cm in diameter
• Presence of at least one B symptom
• Fever (\>38 C), night sweats, weight loss \> 10% in the past 6 months
• Symptomatic splenomegaly (or size \>13cm)
• Impending organ compression or involvement (ureteral, orbital, gastrointestinal)

You may not qualify if:

• Subjects will be ineligible for this study if they meet any of following criteria:
• Known active central nervous system lymphoma or leptomeningeal disease.
• Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first investigational agent administration.
• Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated localized skin cancer without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk.
• Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2.
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
• History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.
• Use of strong/moderate inhibitors within 7 days or 5 half-lives prior to the first dose of zanubrutinib; usage of strong/moderate CYP3A inducers within 14 days prior to the first dose of zanubrutinib.
• Requiring ongoing therapy with strong or moderate CYP3A inducers.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
• Significant screening electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block.
• Active bleeding or known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dai Chihara, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dai Chihara, MD,PHD

CONTACT

713-794-3074; dchihara@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 20, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)