Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

NCT06442475 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1124175NCI-2024-0228920417
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.

Conditions

Ann Arbor Stage II Marginal Zone Lymphoma; Ann Arbor Stage III Follicular Lymphoma; Ann Arbor Stage IV Follicular Lymphoma; Ann Arbor Stage IV Marginal Zone Lymphoma; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3a Follicular Lymphoma; Ann Arbor Stage II Follicular Lymphoma; Ann Arbor Stage III Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response (OR)

  OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.

  Up to week 13

Secondary Outcomes (7)

• Incidence of adverse events (AE's)

  Up to 30 days after last dose of study treatment

• Incidence of grade 3 or greater cytokine release syndrome (CRS)

  Up to 30 days after last dose of study treatment

• Incidence of Immune Effector Cell Associated Neurotoxicity syndrome

  Up to 30 days after last dose of study treatment

• Progression free survival (PFS)

  At initiation of study treatment to disease progression, up to 5 years

• Duration of response

  Up to 5 years

Study Arms (1)

Treatment (mosunetuzumab)

EXPERIMENTAL

Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Mosunetuzumab; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood, oral, and/or rectal sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (mosunetuzumab)

Computed Tomography PROCEDURE

Undergo PET/CT or CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (mosunetuzumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (mosunetuzumab)

Mosunetuzumab BIOLOGICAL

Given IV

Also known as: Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A, BTCT-4465A, BTCT4465A, CD20/CD3 BiMAb BTCT4465A, Lunsumio, Mosunetuzumab-axgb, RG 7828, RG-7828, RG7828, RO7030816

Treatment (mosunetuzumab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (mosunetuzumab)

Questionnaire Administration OTHER

Ancillary studies

Treatment (mosunetuzumab)

Eligibility Criteria

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

You may qualify if:

• years or older at time of signing informed consent
• Capable of understanding and providing written informed consent
• Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
• Follicular lymphoma (grade 1-2 or 3A)
• Marginal zone lymphoma
• Ann Arbor stage II-IV disease
• No prior therapy for lymphoma
• Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
• Nodal or extranodal tumor mass \< 7 cm
• Involvement of less than 3 nodal sites with a diameter \> 3 cm
• No systemic or B symptoms
• No splenomegaly \> 16 cm by imaging
• No local risk of vital organ compression
• No pleural or peritoneal serous effusions
• No leukemic phase (\> 5,0000/ uL circulating lymphocytes)

You may not qualify if:

• History of severe allergic reaction to monoclonal antibody therapy
• History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
• Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
• Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
• Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HbBsAg\] serology):
• Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
• Autoimmune disease requiring active therapy
• History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
• Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
• Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
• Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
• Prior solid organ transplantation
• Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Ajay Gopal

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Gopal

CONTACT

206-606-2037; agopal@uw.edu

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: May 29, 2024
• First Posted: June 4, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): February 12, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)