Lymphoma patients may get a simpler shot option

NCT ID NCT05207670

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This phase 2 trial tests a drug called mosunetuzumab, given as a shot under the skin, for people with certain types of non-Hodgkin lymphoma. The study includes 320 participants and aims to see if the drug can shrink tumors or delay cancer growth. Researchers are also checking for side effects like cytokine release syndrome, which can be treated with another drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: mosunetuzumab
What this could lead to: If successful, this could provide a more convenient subcutaneous treatment option for certain B-cell lymphomas, potentially improving disease control.
What could go wrong: This is a mid-stage trial with no control group, so results are preliminary. Side effects like cytokine release syndrome (CRS) are possible, and the drug may not work for all lymphoma types studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

320 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 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 65-79 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 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 (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 regimen containing a Bruton's tyrosine kinase (BTK) inhibitor * Adequate renal function * Adverse events from prior anti-cancer therapy resolved to Grade \</= 1 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 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: * 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 \</= 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 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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-Hodgkin lymphoma

Contacts and locations

Locations

Alaska Oncology & Hematology, LLC

Anchorage, Alaska, 99508, United States
American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817-1915, United States
Astera Cancer Care East Brunswick

East Brunswick, New Jersey, 08816, United States
Cancer Specialists of North Florida - Jacksonville

Jacksonville, Florida, 32256, United States
City of Hope

Duarte, California, 91010, United States
Florida Cancer Specialists - EAST - SCRI - PPDS

West Palm Beach, Florida, 33401-3406, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS

St. Petersburg, Florida, 33705-1449, United States
Infirmary Cancer Care

Mobile, Alabama, 36607-3513, United States
Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336-7774, United States
Kaiser Foundation Hospitals

Portland, Oregon, 97227, United States
Mayo Clinic - PPDS

Rochester, Minnesota, 55905, United States
Mayo Clinic Arizona

Phoenix, Arizona, 85054-4504, United States
Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, 32224-1865, United States
McGlinn Cancer Institute at Reading Hospital

West Reading, Pennsylvania, 19611, United States
Medical Oncology Hematology Consultants

Newark, Delaware, 19713-2055, United States
Mission Blood and Cancer - MercyOne Cancer Center

Des Moines, Iowa, 50314-3030, United States
MultiCare Deaconess Cancer and Blood Specialty Center

Spokane, Washington, 99218-8205, United States
NY Cancer & Blood Specialist

New York, New York, 10028-0506, United States
New York Cancer & Blood Specialists - Bronx

The Bronx, New York, 10469-5930, United States
New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York, 11042-1116, United States
New York Oncology Hematology, P.C.

Albany, New York, 12206, United States
North Shore Hematology Oncology Association PC

Shirley, New York, 11967, United States
Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States
Oncology Hematology Care - SCRI

Zachary, Louisiana, 70791, United States
Oncology Hematology Care Inc - Cincinnati - USOR

Cincinnati, Ohio, 45236-2725, United States
Providence Cancer Institute

Portland, Oregon, 97213-2933, United States
Rocky Mountain Cancer Centers (Aurora) - USOR

Aurora, Colorado, 80012-5405, United States
SCRI Florida Cancer Specialists South

Fort Myers, Florida, 33916, United States
San Juan Oncology Associates

Farmington, New Mexico, 87401, United States
St. Vincent Frontier Cancer Center

Billings, Montana, 59101, United States
Tennessee Oncology - Nashville

Nashville, Tennessee, 37203, United States
Tennessee Oncology Chattanooga

Chattanooga, Tennessee, 37404-3230, United States
Texas Oncology (Amarillo) - USOR - 1826 Point West Pkwy

Amarillo, Texas, 79124-2167, United States
Texas Oncology (Tyler) - USOR

Tyler, Texas, 75702-8363, United States
Texas Oncology (Worth) - USOR

Dallas, Texas, 75246-2008, United States
Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States
University of Kansas Medical Center

Westwood, Kansas, 66205, United States
VA Puget Sound Health Care System - NAVREF - PPDS

Seattle, Washington, 98108-1532, United States
Virginia Cancer Specialists - Gainsville

Gainesville, Virginia, 20155-3257, United States

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