AzTrials
AzTrials

Ann Arbor Stage II Follicular LymphomaPhase 2NCT06442475

Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Ann Arbor Stage II Follicular Lymphoma and Ann Arbor Stage II Marginal Zone Lymphoma, run by University of Washington 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

This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
29 Aug 2024to 12 Feb 2028
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

  • 18 years or older at time of signing informed consent
  • Capable of understanding and providing written informed consent
  • Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
  • Follicular lymphoma (grade 1-2 or 3A)
  • Marginal zone lymphoma
  • Ann Arbor stage II-IV disease
Show all 25Show fewer
  • No prior therapy for lymphoma
  • Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
  • Nodal or extranodal tumor mass < 7 cm
  • Involvement of less than 3 nodal sites with a diameter > 3 cm
  • No systemic or B symptoms
  • No splenomegaly > 16 cm by imaging
  • No local risk of vital organ compression
  • No pleural or peritoneal serous effusions
  • No leukemic phase (> 5,0000/ uL circulating lymphocytes)
  • No significant cytopenias defined as platelets < 100,000/uL, hemoglobin < 10 g/dL, or absolute neutrophil count (ANC) < 1500/ uL
  • Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
  • Aspartate aminotransferase (AST) ≤ 3 x the ULN
  • Alanine aminotransferase (ALT) ≤ 3 x the ULN
  • Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
  • Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
  • Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab

Who cannot join

  • History of severe allergic reaction to monoclonal antibody therapy
  • History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
  • Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
  • Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
  • Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbBsAg] serology):
  • Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
Show all 13Show fewer
  • Autoimmune disease requiring active therapy
  • History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
  • Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
  • Prior solid organ transplantation
  • Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab

Trial locations and contacts

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

Ajay Gopal contact

206-606-2037

agopal@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Ajay Gopal, 206-606-2037, agopal@uw.edu

    Ajay Gopal

    Recruiting

Other trials in United States

About this study

Official title: Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma

This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

OUTLINE:

Patients receive mosunetuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) on study. Patients may undergo CT and/or magnetic resonance imaging (MRI) as clinically indicated and may undergo collection of oral and/or rectal swabs on study.

After completion of study treatment, patients are followed up at week 13, at 6 months, and then for up to 5 years per institutional standards.

Being tested
Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Mosunetuzumab, Positron Emission Tomography
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood, oral, and/or rectal sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT or CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MosunetuzumabBiological

    Also called Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A, BTCT-4465A, BTCT4465A

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06442475
Study groupRoleWhat they receive
Treatment (mosunetuzumab)ExperimentalPatients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Mosunetuzumab; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

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

  1. Overall response (OR)

    OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.

    Measured: Up to week 13

Secondary outcomes (7)

  1. Incidence of adverse events (AE's)

    All AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by type, severity, duration, and attribution.

    Measured: Up to 30 days after last dose of study treatment

  2. Incidence of grade 3 or greater cytokine release syndrome (CRS)

    CRS will be graded by the American Society for Transplantation and Cellular Therapy Consensus Grading system.

    Measured: Up to 30 days after last dose of study treatment

  3. Incidence of Immune Effector Cell Associated Neurotoxicity syndrome

    Measured: Up to 30 days after last dose of study treatment

  4. Progression free survival (PFS)

    Kaplan-Meier methodology will be used to estimate PFS.

    Measured: At initiation of study treatment to disease progression, up to 5 years

  5. Duration of response

    Measured: Up to 5 years

  6. Time to next lymphoma treatment

    Kaplan-Meier methodology will be used to estimate time to next lymphoma treatment.

    Measured: At initiation of study treatment to initiation of next therapy, up to 5 years

  7. Time to cytotoxic treatment

    Kaplan-Meier methodology will be used to estimate time to cytotoxic treatment.

    Measured: At initiation of study treatment to initiation of cytotoxic treatment, up to 5 years

Timeline

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

  1. First posted4 Jun 2024
  2. Study start29 Aug 2024
  3. Primary completion12 Aug 2027 (estimated)
  4. Study completion12 Feb 2028 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06442475
Sponsor's protocol ID
RG1124175
Other IDs
NCI-2024-02289, 20417
Status last verified
Aug 2026
First submitted
29 May 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Ann Arbor Stage II Follicular Lymphoma and Ann Arbor Stage II Marginal Zone Lymphoma, run by University of Washington 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 25 inclusion and 13 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 27 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 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 Ajay Gopal (206-606-2037, agopal@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response (OR) (time frame: Up to week 13). 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 NCT06442475.

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 27 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in