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Non-Hodgkin LymphomaPhase 2MorningSunNCT05207670

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

A Phase 2 study testing Mosunetuzumab (Cohorts A-C), Mosunetuzumab (Cohorts D-E) and Tocilizumab in people with Non-Hodgkin Lymphoma, run by Genentech, Inc. at 39 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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]). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
Mosunetuzumab (Cohorts A-C), Mosunetuzumab (Cohorts D-E) and Tocilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
39 sitesUnited States
Study dates
1 Feb 2022to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

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

    Amarillo, Texas, 79124-2167

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508

  • Rocky Mountain Cancer Centers (Aurora) - USOR

    Aurora, Colorado, 80012-5405

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817-1915

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59101

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404-3230

  • Oncology Hematology Care Inc - Cincinnati - USOR

    Cincinnati, Ohio, 45236-2725

  • Texas Oncology (Worth) - USOR

    Dallas, Texas, 75246-2008

  • Mission Blood and Cancer - MercyOne Cancer Center

    Des Moines, Iowa, 50314-3030

  • City of Hope

    Duarte, California, 91010

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • Virginia Cancer Specialists - Gainsville

    Gainesville, Virginia, 20155-3257

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida, 32224-1865

  • Cancer Specialists of North Florida - Jacksonville

    Jacksonville, Florida, 32256

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336-7774

  • Infirmary Cancer Care

    Mobile, Alabama, 36607-3513

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • New York Cancer & Blood Specialists - New Hyde Park

    New Hyde Park, New York, 11042-1116

  • NY Cancer & Blood Specialist

    New York, New York, 10028-0506

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713-2055

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054-4504

  • Providence Cancer Institute

    Portland, Oregon, 97213-2933

  • Kaiser Foundation Hospitals

    Portland, Oregon, 97227

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905

  • VA Puget Sound Health Care System - NAVREF - PPDS

    Seattle, Washington, 98108-1532

  • North Shore Hematology Oncology Association PC

    Shirley, New York, 11967

  • MultiCare Deaconess Cancer and Blood Specialty Center

    Spokane, Washington, 99218-8205

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    St. Petersburg, Florida, 33705-1449

  • New York Cancer & Blood Specialists - Bronx

    The Bronx, New York, 10469-5930

  • Texas Oncology (Tyler) - USOR

    Tyler, Texas, 75702-8363

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    West Palm Beach, Florida, 33401-3406

  • McGlinn Cancer Institute at Reading Hospital

    West Reading, Pennsylvania, 19611

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

  • Oncology Hematology Care - SCRI

    Zachary, Louisiana, 70791

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Mosunetuzumab Monotherapy in Patients With Select B-Cell Malignancies

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]).

Being tested
Mosunetuzumab (Cohorts A-C), Mosunetuzumab (Cohorts D-E), Tocilizumab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mosunetuzumab (Cohorts A-C)Drug

    Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only)

  • Mosunetuzumab (Cohorts D-E)Drug

    Participants will receive SC mosunetuzumab for up to 34 cycles

  • TocilizumabDrug

    Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab

Study groups in NCT05207670
Study groupRoleWhat they receive
Cohort AExperimentalParticipants 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.
Receives: Drug: Mosunetuzumab (Cohorts A-C); Drug: Tocilizumab
Cohort BExperimentalElderly 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.
Receives: Drug: Mosunetuzumab (Cohorts A-C); Drug: Tocilizumab
Cohort CExperimentalParticipants 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.
Receives: Drug: Mosunetuzumab (Cohorts A-C); Drug: Tocilizumab
Cohort DExperimentalParticipants 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.
Receives: Drug: Mosunetuzumab (Cohorts D-E); Drug: Tocilizumab
Cohort EExperimentalParticipants 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.
Receives: Drug: Mosunetuzumab (Cohorts D-E); Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B)

    Measured: From the first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by the investigator according to Lugano Criteria 2014 (minimum 2 years)

  2. Objective response rate (ORR), defined as the proportion of participants with a complete metabolic response (CMR) or partial response (PR), as determined by the investigator according to the Lugano Criteria 2014 (Cohorts C, D, and E)

    Measured: Cycles 4, 8, 12 and 17 (cycle length=21 days)

Secondary outcomes (10)

  1. Overall survival (OS) (all cohorts)

    Measured: From first study treatment to death from any cause (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)

  2. ORR, defined as the proportion pf participants with a CMR or PR, as determined by the investigator according to the Lugano Criteria 2014 (Cohorts A1, A2, and B)

    Measured: Cycles 4, 8, 12 and 17 (cycle length=21 days)

  3. Time to response (TTR) (all cohorts)

    Measured: From first study treatment to the first occurrence of a documented objective response observed for patients who achieved a CMR or PR (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)

  4. Duration of response (DOR) (all cohorts)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)

  5. DOR for participants with best response of CMR (all cohorts)

    Measured: From documentation of CMR to the time of progression or death, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)

  6. Duration of complete response (DoCR) (all cohorts)

    Measured: From documentation of CMR to the time of progression or death, whichever occurs first (minimum 2 years for Cohorts A1 - C or 1 year for Cohorts D and E)

  7. Time to next treatment (TTNT) (all cohorts)

    Measured: From first study treatment to the start of new anti-lymphoma therapy (NALT) or death (minimum 2 years for Cohorts A1-C or 1 year for Cohorts D and E)

  8. PFS (all cohorts)

    Measured: From first study treatment to first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by investigator according to Lugano Criteria 2014 (min. 2 years for Cohorts A1 - C or 1 year for Cohorts D, E)

  9. Percentage of participants with adverse events (AEs) (all cohorts)

    Measured: Minimum 2 years for Cohorts A-C or 1 year for Cohorts D and E

  10. Serum concentration of mosunetuzumab (all cohorts)

    Measured: Cycle 1 Days 1,2,8,15; thereafter Day 1 of Cycles 2,3,4,6,8,12,16 (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207670
Sponsor's protocol ID
ML43389
Acronym
MorningSun
Status last verified
Aug 2026
First submitted
15 Dec 2021
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mosunetuzumab (Cohorts A-C), Mosunetuzumab (Cohorts D-E) and Tocilizumab in people with Non-Hodgkin Lymphoma, run by Genentech, Inc. at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B) (time frame: From the first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by the investigator according to Lugano Criteria 2014 (minimum 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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