A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

September 11, 2026 updated by: Hoffmann-La Roche

A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Shanghai, China, 200120
        • Fudan University Shanghai Cancer Center
      • Tianjing, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Xiamen, China, 361003
        • The First Affiliated Hospital Of Xiamen University
  • France
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier LYON SUD
      • Rennes, France, 35033
        • CHU Rennes - Hôpital Pontchaillou
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz.
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals NHS Foundation Trust - University College Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust - City Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
    • Florida
      • Miami, Florida, United States, 33136-1002
        • University of Miami Miller School of Medicine
    • Kentucky
      • Louisville, Kentucky, United States, 40207-4723
        • Norton Cancer Institute - St. Matthews
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Ctr
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Of Michigan Comprehensive Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital
    • Rhode Island
      • Woonsocket, Rhode Island, United States, 02895-4720
        • Rhode Island Hematology/Oncology Program
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology;Chattanooga Oncology & Hematology Associates
      • Franklin, Tennessee, United States, 37067
        • Tennessee Oncology PLLC - Franklin
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • R/R FL after treatment with at least one prior systemic lymphoma therapy, which includes prior immunotherapy or chemoimmunotherapy
  • Previously untreated participants with FL must require systemic therapy assessed by investigator based on the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria and have a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5
  • Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 at time of diagnosis as determined by the local laboratory
  • Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)
  • At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
  • Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of FL
  • Adequate hematologic function (unless due to underlying lymphoma, per the investigator) as defined by the protocol
  • 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/mL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
  • Normal laboratory values (unless due to underlying lymphoma) as defined by the protocol
  • Agreement to comply with all local requirements of the Len risk minimization plan
  • For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period, and for at least 12 months after the final dose of glofitamab, 28 days after the last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun. Women must refrain from donating eggs during this same period
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun

Exclusion Criteria

  • Any history of Grade 3b FL
  • Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment
  • Any history of disease transformation and/or diffuse large B-cell lymphoma (DLBCL)
  • Documented refractoriness to an obinutuzumab monotherapy containing regimen in glofitamab-containing treatment combination
  • Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
  • Documented refractoriness to lenalidomide, defined as no response (partial response (PR) or complete response (CR)) within 6 months of therapy
  • Prior standard or investigational anti-cancer therapy as specified by the protocol
  • Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
  • Known history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
  • Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
  • Known sensitivity or allergy to murine products
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the glofitamab, Mosun, G, Len, or thalidomide formulation, including mannitol
  • History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
  • Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
  • Known or suspected chronic active Epstein-Barr virus infection or hemophagocytic syndrome
  • Known history of macrophage activating syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
  • Active Hepatitis B and Hepatitis C infection or autoimmune disease requiring treatment
  • Prior allogenic hematopoietic stem cell transplant
  • Known history of HIV positive status
  • History of progressive multifocal leukoencephalopathy
  • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Other malignancy that could affect compliance with the protocol or interpretation of results
  • Prior allogenic hematopoietic stem cell transplant (HSCT)
  • Contraindication to treatment for thromboembolism prophylaxis
  • Grade >=2 neuropathy
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to significant cardiovascular disease or significant pulmonary disease
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Inadequate hematologic function
  • Any of the following abnormal laboratory values
  • Pregnant or lactating or intending to become pregnant during the study
  • Life expectancy < 3 months
  • Unable to comply with the study protocol, in the investigator's judgment
  • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Mosunetuzumab (IV)
Participants will receive IV mosunetuzumab as defined by the study protocol
Other Names:
  • RO7030816
Drug: Tocilizumab
Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
Other Names:
  • RO4877533
Drug: Lenalidomide
Participants will receive oral lenalidomide as defined by the study protocol
Experimental: Arm A: IV Mosunetuzumab + Len (Randomized)
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Mosunetuzumab (IV)
Participants will receive IV mosunetuzumab as defined by the study protocol
Other Names:
  • RO7030816
Drug: Lenalidomide
Participants will receive oral lenalidomide as defined by the study protocol
Experimental: Arm B: SC Mosunetuzumab + Len (Randomized)
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Lenalidomide
Participants will receive oral lenalidomide as defined by the study protocol
Drug: Mosunetuzumab (SC)
Participants will receive SC mosunetuzumab as defined by the study protocol
Other Names:
  • RO7030816
Experimental: Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles.
Drug: Tocilizumab
Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
Other Names:
  • RO4877533
Drug: Lenalidomide
Participants will receive oral lenalidomide as defined by the study protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 2 Days 1-28 (cycle length = 28 days)
Cycle 2 Days 1-28 (cycle length = 28 days)
Percentage of Participants with Adverse Events
Time Frame: From baseline to 90 days after the last dose of study drug
From baseline to 90 days after the last dose of study drug
Cumulative Area under the Curve over Cycles 1-3 (AUC1-3) of Mosunetuzumab
Time Frame: Day 1 - Day 78
Day 1 - Day 78
Serum Trough Concentration at Steady State Approximated by Cycle 4 (Ctrough, c4) of Mosunetuzumab
Time Frame: Day 106
Day 106
Overall Response Rate (ORR) as Determined by the Independent Review Committee (IRC)
Time Frame: Up to the end of Cycle 12 (cycle length = 28 days)
Up to the end of Cycle 12 (cycle length = 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Minimum Serum Concentration (Cmin) of Mosunetuzumab
Time Frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Maximum Serum Concentration (Cmax) of Mosunetuzumab
Time Frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Percentage of Participants with ADAs to Mosunetuzumab
Time Frame: At pre-defined intervals from baseline through follow-up (2 years after last treatment)
At pre-defined intervals from baseline through follow-up (2 years after last treatment)
Percentage of Participants with AEs (Arms A and B)
Time Frame: From baseline to 90 days after the last dose of study drug
From baseline to 90 days after the last dose of study drug
Cumulative AUC Over Cycles 1-2 (AUCc1-2) of Mosunetuzumab (Arms A and B)
Time Frame: Day 1 - Day 50
Day 1 - Day 50
Serum Trough Concentration in Cycle 2 (Ctrough, c2) of Mosunetuzumab (Arms A and B)
Time Frame: Day 50
Day 50
AUC at Steady State (AUCss) (Arms A and B)
Time Frame: Cycle 4 (cycle length = 28 days)
Cycle 4 (cycle length = 28 days)
Complete Response Rate (CRR) as determined by the investigator (non-randomized stage)
Time Frame: Up to the end of Cycle 12 (cycle length = 28 days)
Up to the end of Cycle 12 (cycle length = 28 days)
CRR as determined by Independent Review Committee (IRC) (randomized stage)
Time Frame: Up to the end of Cycle 12 (cycle length = 28 days)
Up to the end of Cycle 12 (cycle length = 28 days)
Objective Response Rate (ORR) as determined by the investigator (non-randomized stage)
Time Frame: Up to the end of Cycle 12 (cycle length = 28 days)
Up to the end of Cycle 12 (cycle length = 28 days)
ORR as determined by IRC (randomized stage)
Time Frame: Up to the end of Cycle 12 (cycle length = 28 days)
Up to the end of Cycle 12 (cycle length = 28 days)
Duration of Response (DOR) as determined by the investigator (non-randomized stage)
Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
DOR as determined by IRC (randomized stage)
Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
Duration of Complete Reponse (DOCR) as determined by the investigator (non-randomized stage)
Time Frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
DOCR as determined by IRC (randomized stage)
Time Frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO41942
  • 2019 (U.S. NIH Grant/Contract: Chief Medical Office (CMO) Alberta Health Services)
  • 2019-004291-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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