A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies

Last updated: March 11, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Marginal Zone Lymphoma

Hematologic Cancer

Non-hodgkin's Lymphoma

Treatment

Mosunetuzumab (Cohorts D-E)

Mosunetuzumab (Cohorts A-C)

Tocilizumab

Clinical Study ID

NCT05207670
ML43389
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).

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

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: Mosunetuzumab (Cohorts D-E)
Phase: 2
Study Start date:
February 01, 2022
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Infirmary Cancer Care

    Mobile, Alabama 36607-3513
    United States

    Site Not Available

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054-4504
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Marin Cancer Care Inc

    Greenbrae, California 94904
    United States

    Active - Recruiting

  • Marin General Hospital

    Greenbrae, California 94904
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers (Aurora) - USOR

    Aurora, Colorado 80012-5405
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants

    Newark, Delaware 19713-2055
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Cancer Specialists of North Florida (AC Skinner Bldg 100)

    Jacksonville, Florida 32256-6932
    United States

    Site Not Available

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida 32224-1865
    United States

    Site Not Available

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    Saint Petersburg, Florida 33705-1449
    United States

    Site Not Available

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    West Palm Beach, Florida 33401-3406
    United States

    Site Not Available

  • St Luke?s Cancer Institute

    Boise, Idaho 83712
    United States

    Site Not Available

  • Mission Blood and Cancer - MercyOne Cancer Center

    Des Moines, Iowa 50314-3030
    United States

    Site Not Available

  • University of Kansas Medical Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817-1915
    United States

    Site Not Available

  • Ascension Health Van Elsander Cancer Center

    Grosse Pointe Woods, Michigan 48236
    United States

    Site Not Available

  • Mayo Clinic - PPDS

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59101
    United States

    Site Not Available

  • Benefis Hospital Sletten Cancer Institute

    Great Falls, Montana 59405-5306
    United States

    Site Not Available

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Englewood Hospital and Medical Center

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Summit Medical Group; MD Anderson Cancer Center

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Atlantic Hematology Oncology

    Morristown, New Jersey 07960-6136
    United States

    Site Not Available

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • San Juan Oncology Associates

    Farmington, New Mexico 87401
    United States

    Site Not Available

  • New York Oncology Hematology, P.C.

    Albany, New York 12206
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - Bronx

    Bronx, New York 10469-5930
    United States

    Site Not Available

  • New York Cancer & Blood Specialists - New Hyde Park

    New Hyde Park, New York 11042-1116
    United States

    Site Not Available

  • NY Cancer & Blood Specialist

    New York, New York 10028-0506
    United States

    Site Not Available

  • North Shore Hematology Oncology Association PC

    Port Jefferson Station, New York 11776-8060
    United States

    Site Not Available

  • North Shore Hematology Oncology Association PC

    Shirley, New York 11967
    United States

    Site Not Available

  • Oncology Hematology Care Inc - Cincinnati - USOR

    Cincinnati, Ohio 45236-2725
    United States

    Site Not Available

  • Hightower Clinical

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Asante Spears Cancer Center

    Grants Pass, Oregon 97527-5554
    United States

    Site Not Available

  • Asante Heimann Cancer Center - Medford

    Medford, Oregon 97504-8301
    United States

    Site Not Available

  • Asante Rogue Regional Medical Center

    Medford, Oregon 97504-8332
    United States

    Site Not Available

  • Kaiser Foundation Hospitals

    Portland, Oregon 97227
    United States

    Site Not Available

  • Providence Cancer Center

    Portland, Oregon 97231
    United States

    Site Not Available

  • Providence Cancer Institute

    Portland, Oregon 97213-2933
    United States

    Site Not Available

  • Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • McGlinn Cancer Institute at Reading Hospital

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Prisma Health Cancer Institute; Research Pharmacy

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee 37404-3230
    United States

    Site Not Available

  • Tennessee Oncology - Nashville

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Oncology PLLC - Franklin

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Tennessee Oncology - Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology NASH - SCRI - PPDS

    Nashville, Tennessee 37203-1503
    United States

    Site Not Available

  • Texas Oncology (Amarillo) - USOR - 1826 Point West Pkwy

    Amarillo, Texas 79124-2167
    United States

    Site Not Available

  • Texas Oncology PA - USOR

    Amarillo, Texas 79106-1781
    United States

    Active - Recruiting

  • Texas Oncology-Austin Midtown

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology (Worth) - USOR

    Dallas, Texas 75246-2008
    United States

    Site Not Available

  • Texas Oncology (Tyler) - USOR

    Tyler, Texas 75702-8363
    United States

    Site Not Available

  • Tennessee Oncology Chattanooga

    Alexandria, Virginia 22304
    United States

    Site Not Available

  • Virginia Cancer Specialists - Gainsville

    Gainesville, Virginia 20155-3257
    United States

    Site Not Available

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington 99336-7774
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98104-1360
    United States

    Site Not Available

  • VA Puget Sound Health Care System - NAVREF - PPDS

    Seattle, Washington 98108-1532
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane, Washington 99202
    United States

    Site Not Available

  • MultiCare Deaconess Cancer and Blood Specialty Center

    Spokane, Washington 99218-8205
    United States

    Site Not Available

  • Multicare Health System

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Northwest Medical Specialties

    Tacoma, Washington 98405
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.