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Extranodal Marginal Zone LymphomaPhase 2NCT06569680

Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

A Phase 2 study testing Mosunetuzumab in people with Extranodal Marginal Zone Lymphoma, run by Izidore Lossos, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extranodal Marginal Zone Lymphoma
What is being tested?
Mosunetuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
19 Nov 2024to 1 Dec 2030
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

  • Men and women aged 18 years or older at the time of signing informed consent.
  • Able and willing to sign the informed consent form (ICF).
  • Ability to comply with the trial protocol.
  • Histologically confirmed EMZL presenting with stage I-IV disease.
  • Previously untreated participants.
  • Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, participant has histologically confirmed MZL.
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  • Participants who were previously treated with localized therapy (eg, radiation or surgery) and never received systemic therapy and present with recurrent disease are eligible upon histological confirmation of MZL.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures >1.5 cm in the longest diameter (LDi) and ≥1.0 cm in the longest perpendicular diameter as assessed by CT or MRI, especially in extranodal sites, per response criteria for lymphomas (Cheson, et al., 2014). Imaging must be conducted within 6 weeks prior to the start of therapy.
  • Participants with skin EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that skin lesion measures ≥1.5 cm in diameter by tape measure and is documented by photo or there are multiple skin lesions measuring >1 cm in diameter on the body and at least one of them is histologically confirmed as EMZL.
  • Participants with gastric EMZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assessed by multiple random gastric biopsies per Groupe d'Etude des Lymphomes de l'Adult (GELA) criteria (Ruskoné Fourmestraux, et al., 2011).
  • Participants with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that conjunctival lesion measures ≥1 cm in diameter by tape measure and is documented by photo or there are multiple conjunctival lesions measuring together >1.5 cm. At least one of the lesions needs be histologically confirmed as EMZL.
  • Participants must be willing to provide tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy. If biopsy can be reviewed to confirm the diagnosis but there is no extra tissue for exploratory studies, such participants can still be enrolled in this trial.
  • Participant should have at least one of the following criteria for treatment initiation:
  • Threatened extranodal organ function
  • Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
  • Any nodal or extranodal tumor mass with a diameter of ≥5 cm
  • B symptoms (fever ≥38 degrees Celsius of unclear etiology, night sweats, weight loss >10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse.
  • Risk of local compressive symptoms that may result in organ compromise
  • Splenomegaly or splenic lesion without splenomegaly
  • Leukopenia attributed to MZL (leukocytes <1000/mm3)
  • Leukemia (>5,000 lymphoma cells/mm3)
  • Requirement for transfusion or growth factor support attributed to lymphoma
  • Involvement of 2 or more extranodal sites, with tumor/lesion in each extranodal site ≥1 cm
  • Life expectancy >3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
  • Absolute neutrophil count (ANC) ≥1.0 × 10^9/L.
  • Hemoglobin ≥8.0 g/dL.
  • Platelet count ≥ 75 × 10^9/L.
  • Total bilirubin ≤1.5 × upper limit normal (ULN). Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
  • Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.
  • Creatinine within normal institutional limits, or
  • calculated creatinine clearance ≥30 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula
  • calculated creatinine clearance ≥35 mL/min by the Cockcroft-Gault Equation (Cockcroft, 1976)
  • estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula for participants with creatinine levels above institutional normal (unless due to lymphoma)
  • Willingness to avoid pregnancy during the trial and for at least 90 days after the last dose of the trial intervention.

Who cannot join

  • Evidence of diffuse large B cell lymphoma (DLBCL) transformation. Participants with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Participants with Dural MZL are eligible.
  • Patients that need immediate cytoreduction.
  • Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
  • Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (>20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1.
  • Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Participants receiving corticosteroids must be at a dose level ≤20 mg/day within 7 days of the trial intervention administration.
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  • The use of inhaled corticosteroids is permitted
  • The use of mineralocorticoids for management of orthostatic hypotension is permitted
  • Single dose of dexamethasone for nausea or B symptoms is permitted
  • Antibiotic treatment of H. pylori-positive gastric EMZL is permitted
  • Allogeneic stem cell transplant, or autologous stem cell transplant or Chimeric antigen receptor T-cell therapy for any indication
  • Active graft versus host disease.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
  • Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
  • Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
  • Chronic or current active infectious disease (including severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2)) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
  • Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.
  • Inactivated influenza vaccinations may be given during the influenza season.
  • An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.
  • Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs)
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol.
  • Significant cardiovascular disease (eg, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • History of progressive multifocal leukoencephalopathy (PML)
  • Active hepatitis B infection
  • Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation
  • Active hepatitis C infection
  • Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation
  • History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Patients with a remote history of, or well-controlled, autoimmune disease with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Patients with a history of disease-related immune thrombocytopenic purpura, or autoimmune hemolytic anemia may be eligible
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • i. Rash must cover 10% of body surface area
  • ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months
  • Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Izidore Lossos, MD contact

305-243-4785

ilossos@med.miami.edu

United States1 site, 1 recruiting

  • University of Miami

    Miami, Florida, 33136

    Izidore Lossos, MD, ilossos@med.miami.edu

    Izidore Lossos, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase II Trial of Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (EMZL) (ML44933)

The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.

Being tested
Mosunetuzumab

What participants receive

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

  • MosunetuzumabDrug

    Also called ML44933, Lunsumio, Mosunetuzumab-axgb

    Mosunetuzumab will be administered via subcutaneous (SC) injection using a step-up dosing model. Participants will receive Mosunetuzumab on days 1, 8, and 15 of Cycle 1, and on day 1 of Cycles 2 through 8 as follows:

    • Cycle 1 Day 1: 5mg
    • Cycle 1 Day 8: 45mg
    • Cycle 1 Day 15: 45mg
    • Cycles 2 through 8, Day 1: 45mg
Study groups in NCT06569680
Study groupRoleWhat they receive
Mosunetuzumab Treatment GroupExperimentalParticipants in this group will receive Mosunetuzumab for eight (8) 21-day cycles. Total participation is about 3.5 years.
Receives: Drug: Mosunetuzumab

What is being measured

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

  1. Complete Response (CR) Rate

    The number of participants with best overall response of complete response (CR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening Fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) (FDG PET/CT) demonstrated FDG-avid disease.

    Measured: Up to 12 months

Secondary outcomes (8)

  1. Overall Response Rate (ORR)

    The number of participants with best overall response of complete response (CR) or partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease.

    Measured: Up to 12 months

  2. Partial Response (PR) Rate

    The number of participants with partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease.

    Measured: Up to 12 months

  3. Number of Participants Experiencing treatment-related adverse events

    The number of participants experiencing toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs), and serious adverse events (SAEs) regardless of attribution. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.

    Measured: Up to 13 months

  4. Number of Participants Experiencing Cytokine Release Syndrome Adverse Events

    The number of participants experiencing cytokine release syndrome (CRS) related adverse events (AEs) will be reported. CRS AEs will be assessed according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus 2019 Grading Criteria.

    Measured: Up to 13 months

  5. Progression-Free Survival (PFS)

    PFS is the elapsed time from start of treatment to documented progressive disease or death from any cause. For participants alive and progression-free, follow-up will be censored at the last date of document progression-free status.

    Measured: Up to 2 years

  6. Time to Response (TTR)

    Time to response (TTR) is defined as elapsed time from start of treatment to achievement of complete response (CR) or partial response (CR).

    Measured: Up to 2 years

  7. Duration of Response (DOR)

    Duration of response (DOR) is the elapsed time from achievement of objective response (CR or PR) to progression, relapse, or death from any cause.

    Measured: Up to 2 years

  8. Overall Survival (OS)

    Overall survival (OS) is the elapsed time from start of treatment to death from any cause. Alive participants will be censored at last date known to be alive.

    Measured: Up to 3 years

Timeline

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

  1. First posted26 Aug 2024
  2. Study start19 Nov 2024
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569680
Sponsor's protocol ID
20240178
Status last verified
Oct 2026
First submitted
22 Aug 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharp J, Shana'ah AY, Voorhees TJ, Bond DA, Sawalha Y, Sigmund A, Hanel W, Sehgal L, Alinari L, Baiocchi R, Maddocks K, Jones D, Christian B, Epperla N. Resistance Mechanism for Zanubrutinib in Marginal Zone Lymphoma. J Natl Compr Canc Netw. 2025 Jun 23;23(7):e257045. doi: 10.6004/jnccn.2025.7045.

    PubMed 40550489

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mosunetuzumab in people with Extranodal Marginal Zone Lymphoma, run by Izidore Lossos, MD at 1 site 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 36 inclusion and 41 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Izidore Lossos, MD (305-243-4785, ilossos@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR) Rate (time frame: Up to 12 months). 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 NCT06569680, which also lists 1 linked publication.

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 15 Oct 2026.

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