Non Hodgkin Lymphoma Clinical Trial

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

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]).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or one bi-dimensionally measurable lesion, defined as >1.0 cm in its 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
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

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 at least 80 years at the time of signing informed consent form (ICF)
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

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, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator
Adequate renal function

Inclusion Criteria Specific to Cohort D

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
Inclusion Criteria Specific to Cohort E

Histologically confirmed RT or tFL
Relapsed after or failed to respond to at least one prior systemic treatment regimen
Adequate renal function
Absolute lymphocyte count Adverse events from prior anti-cancer therapy resolved to Grade
Exclusion Criteria:

Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
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 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 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

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 first mosunetuzumab administration

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05207670

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 37 Locations for this study

See Locations Near You

Alaska Oncology & Hematology, LLC
Anchorage Alaska, 99508, United States
City of Hope
Duarte California, 91010, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora Colorado, 80012, United States
Medical Oncology Hematology Consultants
Newark Delaware, 19713, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Cancer Specialists of North Florida (AC Skinner Bldg 100)
Jacksonville Florida, 32256, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach Florida, 33401, United States
Mission Blood and Cancer - MercyOne Cancer Center
Des Moines Iowa, 50314, United States
University of Kansas Medical Center
Westwood Kansas, 66205, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59101, United States
Benefis Hospital Sletten Cancer Institute
Great Falls Montana, 59405, United States
Astera Cancer Care East Brunswick
East Brunswick New Jersey, 08816, United States
Atlantic Hematology Oncology
Morristown New Jersey, 07960, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
New York Cancer & Blood Specialists - Bronx
Bronx New York, 10469, United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park New York, 11042, United States
NY Cancer & Blood Specialist
New York New York, 10028, United States
North Shore Hematology Oncology Association PC
Port Jefferson Station New York, 11776, United States
Asante Spears Cancer Center
Grants Pass Oregon, 97527, United States
Asante Rogue Regional Medical Center
Medford Oregon, 97504, United States
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute
Springfield Oregon, 97477, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
Prisma Health Cancer Institute; Research Pharmacy
Greenville South Carolina, 29605, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville Tennessee, 37203, United States
Texas Oncology PA - USOR
Amarillo Texas, 79106, United States
Texas Oncology-Austin Midtown
Austin Texas, 78705, United States
Texas Oncology (Worth) - USOR
Dallas Texas, 75246, United States
Texas Oncology (Tyler) - USOR
Tyler Texas, 75702, United States
Virginia Cancer Specialists - Gainsville
Gainesville Virginia, 20155, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Multicare Health System
Spokane Washington, 99204, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05207670

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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