Phase
Condition
Marginal Zone Lymphoma
Hematologic Cancer
Non-hodgkin's Lymphoma
Treatment
Mosunetuzumab (Cohorts D-E)
Mosunetuzumab (Cohorts A-C)
Tocilizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in itslongest dimension, or one bi-dimensionally measurable lesion, defined as >1.0 cm inits longest diameter by computed tomography (CT) scan, positivie emission tomography
computed tomography (PET- CT), or magnetic resonance imaging (MRI)
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 apositive HIV test at screening are eligible provided they are stable onantiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/µL, have anundetectable viral load, and have not had a history of opportunistic infectionattributable to AIDS within the last 12 months
For women of childbearing potential (except those in Cohort B): agreement to remainabstinent (refrain from heterosexual intercourse) or use contraceptive measures, andagreement to refrain from donating eggs, as defined by the protocol
For men: agreement to remain abstinent (refrain from heterosexual intercourse) oruse a condom, and agreement to refrain from donating sperm, as defined by theprotocol
Inclusion Criteria Specific to Cohorts A1 and A2
Previously untreated FL with indication to start systemic therapy
Adequate renal function
Inclusion Criteria Specific to Cohort B
Aged ≥ 80 years at the time of signing informed consent form (ICF), or aged 65-79years and considered ineligible for chemoimmunotherapy (R-CHOP) with at least one ofthe following: Impairment in ≥ 2 Activities of Daily Living (ADL); impairment in ≥ 2Instrumental Activities of Daily Living (IADL); or Cumulative Illness RatingScale-Geriatric (CIRS-G) score of ≥ 1 comorbidity with a severity of 3-4 or a scoreof 2 in ≥ 8 comorbidities
Histologically confirmed DLBCL according to WHO 2016 classification expected toexpress the CD20 antigen (Swerdlow et al. 2016)
Previously untreated DLBCL with indication to start systemic therapy and are noteligible for curative therapy
High-grade B-cell lymphomas, not otherwise specified (HGBL NOS) and HGBL with MYCand B-cell lymphoma (BCL)-2 and/or BCL-6 rearrangements
Adequate end-organ function
Inclusion Criteria Specific to Cohort C
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, orrelapsed following antibiotic therapy and requires therapy, as assessed by theinvestigator (for cases of gastric/MALT MZL)
Adequate renal function
Inclusion Criteria Specific to Cohort D
Histologically confirmed MCL
Relapsed after or failed to respond to at least one prior treatment regimencontaining a Bruton's tyrosine kinase (BTK) inhibitor
Adequate renal function
Adverse events from prior anti-cancer therapy resolved to Grade
Inclusion Criteria Specific to Cohort E
Histologically confirmed RT or tFL
Relapsed after or failed to respond to at least one prior systemic treatment regimenfor RT or tFL
Adequate renal function
Absolute lymphocyte count
Adverse events from prior anti-cancer therapy resolved to Grade
Exclusion
Exclusion Criteria:
Current or past history of central nervous system (CNS) lymphoma or leptomeningealinfiltration
Prior treatment with mosunetuzumab
History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal 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)/hemophagocyticlymphohistiocytosis (HLH)
Positive test results for chronic hepatitis B infection (HBV), acute or chronichepatitis C virus (HCV) infection, or known or suspected HIV infection
Administration of a live, attenuated vaccine within 4 weeks before firstmosunetuzumab administration or anticipation that such a live, attenuated vaccinewill 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-phospholipidsyndrome, 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 necrosisfactor agents) with the exception of corticosteroid treatment
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative disease
History of other malignancy that could affect compliance with the protocol orinterpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affectcompliance with the protocol or interpretation of results or that could increaserisk 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 episodeof 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 superficiallymph 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
Significant cardiovascular disease (such as New York Heart Association Class III orIV cardiac disease, congestive heart failure, myocardial infarction within theprevious 6 months, unstable arrhythmias, or unstable angina) or significantpulmonary disease (including obstructive pulmonary disease and history ofbronchospasm)
History of severe allergic or anaphylactic reaction to humanized, chimeric or murinemonoclonal antibodies (MAbs)
Contraindication to tocilizumab
Prior anti-lymphoma treatment with monoclonal antibodies, radioimmunoconjugates, orantibody-drug conjugates within 4 weeks before first mosunetuzumab administration
Exclusion Criteria Specific to Cohorts D and E
- Prior anti-lymphoma treatment with any monoclonal antibody (e.g., anti-CD20),radioimmunoconjugate, or antibody-drug conjugate therapy within 4 weeks before firstmosunetuzumab administration
Study Design
Connect with a study center
Auxilio Mutuo Cancer Center
San Juan, 00918
Puerto RicoSite Not Available
Infirmary Cancer Care
Mobile, Alabama 36607-3513
United StatesSite Not Available
Alaska Oncology & Hematology, LLC
Anchorage, Alaska 99508
United StatesSite Not Available
Mayo Clinic Arizona
Phoenix, Arizona 85054-4504
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Marin Cancer Care Inc
Greenbrae, California 94904
United StatesActive - Recruiting
Marin General Hospital
Greenbrae, California 94904
United StatesSite Not Available
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado 80012-5405
United StatesSite Not Available
Medical Oncology Hematology Consultants
Newark, Delaware 19713-2055
United StatesSite Not Available
SCRI Florida Cancer Specialists South
Fort Myers, Florida 33916
United StatesSite Not Available
Cancer Specialists of North Florida (AC Skinner Bldg 100)
Jacksonville, Florida 32256-6932
United StatesSite Not Available
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida 32224-1865
United StatesSite Not Available
Florida Cancer Specialists - NORTH - SCRI - PPDS
Saint Petersburg, Florida 33705-1449
United StatesSite Not Available
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida 33401-3406
United StatesSite Not Available
St Luke?s Cancer Institute
Boise, Idaho 83712
United StatesSite Not Available
Mission Blood and Cancer - MercyOne Cancer Center
Des Moines, Iowa 50314-3030
United StatesSite Not Available
University of Kansas Medical Center
Westwood, Kansas 66205
United StatesSite Not Available
Hematology Oncology Clinic
Baton Rouge, Louisiana 70809
United StatesSite Not Available
American Oncology Partners of Maryland, PA
Bethesda, Maryland 20817-1915
United StatesSite Not Available
Ascension Health Van Elsander Cancer Center
Grosse Pointe Woods, Michigan 48236
United StatesSite Not Available
Mayo Clinic - PPDS
Rochester, Minnesota 55905
United StatesSite Not Available
St. Vincent Frontier Cancer Center
Billings, Montana 59101
United StatesSite Not Available
Benefis Hospital Sletten Cancer Institute
Great Falls, Montana 59405-5306
United StatesSite Not Available
Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816
United StatesSite Not Available
Englewood Hospital and Medical Center
Englewood, New Jersey 07631
United StatesSite Not Available
Summit Medical Group; MD Anderson Cancer Center
Florham Park, New Jersey 07932
United StatesSite Not Available
Atlantic Hematology Oncology
Morristown, New Jersey 07960-6136
United StatesSite Not Available
Overlook Medical Center
Summit, New Jersey 07901
United StatesSite Not Available
San Juan Oncology Associates
Farmington, New Mexico 87401
United StatesSite Not Available
New York Oncology Hematology, P.C.
Albany, New York 12206
United StatesSite Not Available
New York Cancer & Blood Specialists - Bronx
Bronx, New York 10469-5930
United StatesSite Not Available
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York 11042-1116
United StatesSite Not Available
NY Cancer & Blood Specialist
New York, New York 10028-0506
United StatesSite Not Available
North Shore Hematology Oncology Association PC
Port Jefferson Station, New York 11776-8060
United StatesSite Not Available
North Shore Hematology Oncology Association PC
Shirley, New York 11967
United StatesSite Not Available
Oncology Hematology Care Inc - Cincinnati - USOR
Cincinnati, Ohio 45236-2725
United StatesSite Not Available
Hightower Clinical
Oklahoma City, Oklahoma 73102
United StatesSite Not Available
Oncology Associates of Oregon, P.C.
Eugene, Oregon 97401
United StatesSite Not Available
Asante Spears Cancer Center
Grants Pass, Oregon 97527-5554
United StatesSite Not Available
Asante Heimann Cancer Center - Medford
Medford, Oregon 97504-8301
United StatesSite Not Available
Asante Rogue Regional Medical Center
Medford, Oregon 97504-8332
United StatesSite Not Available
Kaiser Foundation Hospitals
Portland, Oregon 97227
United StatesSite Not Available
Providence Cancer Center
Portland, Oregon 97231
United StatesSite Not Available
Providence Cancer Institute
Portland, Oregon 97213-2933
United StatesSite Not Available
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
Springfield, Oregon 97477
United StatesSite Not Available
Lancaster General Hospital
Lancaster, Pennsylvania 17604
United StatesSite Not Available
McGlinn Cancer Institute at Reading Hospital
West Reading, Pennsylvania 19611
United StatesSite Not Available
Prisma Health Cancer Institute; Research Pharmacy
Greenville, South Carolina 29605
United StatesSite Not Available
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404-3230
United StatesSite Not Available
Tennessee Oncology - Nashville
Franklin, Tennessee 37067
United StatesSite Not Available
Tennessee Oncology PLLC - Franklin
Franklin, Tennessee 37067
United StatesActive - Recruiting
Tennessee Oncology - Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee 37203-1503
United StatesSite Not Available
Texas Oncology (Amarillo) - USOR - 1826 Point West Pkwy
Amarillo, Texas 79124-2167
United StatesSite Not Available
Texas Oncology PA - USOR
Amarillo, Texas 79106-1781
United StatesActive - Recruiting
Texas Oncology-Austin Midtown
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology (Worth) - USOR
Dallas, Texas 75246-2008
United StatesSite Not Available
Texas Oncology (Tyler) - USOR
Tyler, Texas 75702-8363
United StatesSite Not Available
Tennessee Oncology Chattanooga
Alexandria, Virginia 22304
United StatesSite Not Available
Virginia Cancer Specialists - Gainsville
Gainesville, Virginia 20155-3257
United StatesSite Not Available
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336-7774
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98104-1360
United StatesSite Not Available
VA Puget Sound Health Care System - NAVREF - PPDS
Seattle, Washington 98108-1532
United StatesSite Not Available
Cancer Care Northwest
Spokane, Washington 99202
United StatesSite Not Available
MultiCare Deaconess Cancer and Blood Specialty Center
Spokane, Washington 99218-8205
United StatesSite Not Available
Multicare Health System
Spokane, Washington 99204
United StatesActive - Recruiting
Northwest Medical Specialties
Tacoma, Washington 98405
United StatesSite Not Available
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