A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies
NCT ID: NCT05207670
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2022-02-01
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
Participants with high tumor burden with untreated follicular lymphoma (FL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. Participants that achieve complete or partial metabolic response will have the option of receiving maintenance therapy with mosunetuzumab every 8 weeks for 1 year.
Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts A-C)
Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)
Cohort B
Elderly participants with untreated diffuse large B-cell lymphoma (DLBCL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts A-C)
Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)
Cohort C
Participants with untreated marginal zone lymphoma (MZL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts A-C)
Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)
Cohort D
Participants with relapsed or refractory (R/R) mantle cell lymphoma (MCL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts D-E)
Participants will receive SC mosunetuzumab for up to 34 cycles
Cohort E
Participants with R/R Richter's transformation (RT), or R/R transformed follicular lymphoma (tFL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts D-E)
Participants will receive SC mosunetuzumab for up to 34 cycles
Interventions
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Tocilizumab
Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab
Mosunetuzumab (Cohorts A-C)
Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)
Mosunetuzumab (Cohorts D-E)
Participants will receive SC mosunetuzumab for up to 34 cycles
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Adequate hematologic function
* No active infection
* Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/µL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
* For women of childbearing potential (except those in Cohort B): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined by the protocol
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol
* Previously untreated FL with indication to start systemic therapy
* Adequate renal function
* Aged ≥ 80 years at the time of signing informed consent form (ICF), or aged 65-79 years and considered ineligible for chemoimmunotherapy (R-CHOP) with at least one of the following: Impairment in ≥ 2 Activities of Daily Living (ADL); impairment in ≥ 2 Instrumental Activities of Daily Living (IADL); or Cumulative Illness Rating Scale-Geriatric (CIRS-G) score of ≥ 1 comorbidity with a severity of 3-4 or a score of 2 in ≥ 8 comorbidities
* Histologically confirmed DLBCL according to WHO 2016 classification expected to express the CD20 antigen (Swerdlow et al. 2016)
* Previously untreated DLBCL with indication to start systemic therapy and are not eligible for curative therapy
* High-grade B-cell lymphomas, not otherwise specified (HGBL NOS) and HGBL with MYC and B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements
* Adequate end-organ function
* Histologically conformed MZL (splenic, nodal, and extra-nodal)
* Previously untreated MZL with indication to start systemic therapy
* Helicobacter pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator (for cases of gastric/MALT MZL)
* Adequate renal function
* Histologically confirmed MCL
* Relapsed after or failed to respond to at least one prior treatment regimen containing a Bruton's tyrosine kinase (BTK) inhibitor
* Adequate renal function
* Adverse events from prior anti-cancer therapy resolved to Grade \</= 1
* Histologically confirmed RT or tFL
* Relapsed after or failed to respond to at least one prior systemic treatment regimen for RT or tFL
* Adequate renal function
* Absolute lymphocyte count \</= 5000 uL
* Adverse events from prior anti-cancer therapy resolved to Grade \</= 1
Exclusion Criteria
* Prior treatment with mosunetuzumab
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* History of confirmed progressive multifocal leukoencephalopathy (PML)
* Known active SARS-CoV-2 infection
* Known or suspected chronic active Epstein-Barr virus (CAEBV) infection
* Patients with history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
* Positive test results for chronic hepatitis B infection (HBV), acute or chronic hepatitis C virus (HCV) infection, or known or suspected HIV infection
* Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab administration or anticipation that such a live, attenuated vaccine will be required during the study
* Prior solid organ transplantation
* Prior allogenic stem cell transplant
* Treatment with CAR-T therapy within 30 days prior to C1D1
* History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
* Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment \</= 10 mg/day prednisone or equivalent within 2 weeks prior to the first dose of mosunetuzumab
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before C1D1
* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
* Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis
* Prior treatment with radiotherapy within 2 weeks prior to C1D1
* Adverse events from prior anti-cancer therapy not resolved to Grade \</= 1 (with the exception of alopecia, anorexia, nausea, vomiting, and fatigue)
* Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs)
* Contraindication to tocilizumab
* Prior anti-lymphoma treatment with monoclonal antibodies, radioimmunoconjugates, or antibody-drug conjugates within 4 weeks before first mosunetuzumab administration
* Prior anti-lymphoma treatment with any monoclonal antibody (e.g., anti-CD20), radioimmunoconjugate, or antibody-drug conjugate therapy within 4 weeks before first mosunetuzumab administration
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Infirmary Cancer Care
Mobile, Alabama, United States
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, United States
Mission Blood and Cancer - MercyOne Cancer Center
Des Moines, Iowa, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Oncology Hematology Care - SCRI
Zachary, Louisiana, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States
NY Cancer & Blood Specialist
New York, New York, United States
North Shore Hematology Oncology Association PC
Shirley, New York, United States
New York Cancer & Blood Specialists - Bronx
The Bronx, New York, United States
Oncology Hematology Care Inc - Cincinnati - USOR
Cincinnati, Ohio, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
Providence Cancer Institute
Portland, Oregon, United States
Kaiser Foundation Hospitals
Portland, Oregon, United States
McGlinn Cancer Institute at Reading Hospital
West Reading, Pennsylvania, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Texas Oncology (Amarillo) - USOR - 1826 Point West Pkwy
Amarillo, Texas, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology (Worth) - USOR
Dallas, Texas, United States
Texas Oncology (Tyler) - USOR
Tyler, Texas, United States
Virginia Cancer Specialists - Gainsville
Gainesville, Virginia, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
VA Puget Sound Health Care System - NAVREF - PPDS
Seattle, Washington, United States
MultiCare Deaconess Cancer and Blood Specialty Center
Spokane, Washington, United States
Countries
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Other Identifiers
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ML43389
Identifier Type: -
Identifier Source: org_study_id
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