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Follicular LymphomaPhase 1/2NCT04246086

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

A Phase 1/2 study testing Mosunetuzumab (IV), Tocilizumab and Lenalidomide in people with Follicular Lymphoma, run by Hoffmann-La Roche at 26 sites in 5 countries.

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 safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Mosunetuzumab (IV), Tocilizumab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
26 sitesin 5 countries
Study dates
12 Aug 2020to 6 Sep 2030
Phase
Phase 1/2
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

  • 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)
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 38Show fewer
  • 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

Trial locations and contacts

26 sites in 5 countries.

26 sites in 5 countries

United States13 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Mary Bird Perkins Cancer Ctr

    Baton Rouge, Louisiana, 70809

  • Tennessee Oncology;Chattanooga Oncology & Hematology Associates

    Chattanooga, Tennessee, 37404

  • Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710-4000

  • Tennessee Oncology PLLC - Franklin

    Franklin, Tennessee, 37067

  • Norton Cancer Institute - St. Matthews

    Louisville, Kentucky, 40207-4723

  • Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136-1002

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Rhode Island Hematology/Oncology Program

    Woonsocket, Rhode Island, 02895-4720

Other trials in United States

China5 sites

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, 300060

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

Other trials in China

United Kingdom4 sites

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

Other trials in United Kingdom

France2 sites

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Spain2 sites

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

About this study

Official title: 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.

Being tested
Mosunetuzumab (IV), Tocilizumab, Lenalidomide, Mosunetuzumab (SC)
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Mosunetuzumab (IV)Drug

    Also called RO7030816

    Participants will receive IV mosunetuzumab as defined by the study protocol

  • TocilizumabDrug

    Also called RO4877533

    Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol

  • LenalidomideDrug

    Participants will receive oral lenalidomide as defined by the study protocol

  • Mosunetuzumab (SC)Drug

    Also called RO7030816

    Participants will receive SC mosunetuzumab as defined by the study protocol

Study groups in NCT04246086
Study groupRoleWhat they receive
Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)ExperimentalParticipants 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)
Receives: Drug: Mosunetuzumab (IV); Drug: Tocilizumab; Drug: Lenalidomide
Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)ExperimentalParticipants 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.
Receives: Drug: Tocilizumab; Drug: Lenalidomide
Arm A: IV Mosunetuzumab + Len (Randomized)ExperimentalParticipants 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)
Receives: Drug: Mosunetuzumab (IV); Drug: Lenalidomide
Arm B: SC Mosunetuzumab + Len (Randomized)ExperimentalParticipants 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)
Receives: Drug: Lenalidomide; Drug: Mosunetuzumab (SC)

What is being measured

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

  1. Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 2 Days 1-28 (cycle length = 28 days)

  2. Percentage of Participants with Adverse Events

    Measured: From baseline to 90 days after the last dose of study drug

  3. Cumulative Area under the Curve over Cycles 1-3 (AUC1-3) of Mosunetuzumab

    Measured: Day 1 - Day 78

  4. Serum Trough Concentration at Steady State Approximated by Cycle 4 (Ctrough, c4) of Mosunetuzumab

    Measured: Day 106

  5. Overall Response Rate (ORR) as Determined by the Independent Review Committee (IRC)

    Measured: Up to the end of Cycle 12 (cycle length = 28 days)

Secondary outcomes (15)

  1. Complete Response Rate (CRR) as determined by the investigator (non-randomized stage)

    Measured: Up to the end of Cycle 12 (cycle length = 28 days)

  2. CRR as determined by Independent Review Committee (IRC) (randomized stage)

    Measured: Up to the end of Cycle 12 (cycle length = 28 days)

  3. Objective Response Rate (ORR) as determined by the investigator (non-randomized stage)

    Measured: Up to the end of Cycle 12 (cycle length = 28 days)

  4. ORR as determined by IRC (randomized stage)

    Measured: Up to the end of Cycle 12 (cycle length = 28 days)

  5. Duration of Response (DOR) as determined by the investigator (non-randomized stage)

    Measured: 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)

  6. DOR as determined by IRC (randomized stage)

    Measured: 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)

  7. Duration of Complete Reponse (DOCR) as determined by the investigator (non-randomized stage)

    Measured: 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)

  8. DOCR as determined by IRC (randomized stage)

    Measured: 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)

  9. Percentage of Participants with AEs (Arms A and B)

    Measured: From baseline to 90 days after the last dose of study drug

  10. Minimum Serum Concentration (Cmin) of Mosunetuzumab

    Measured: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)

  11. Maximum Serum Concentration (Cmax) of Mosunetuzumab

    Measured: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)

  12. Cumulative AUC Over Cycles 1-2 (AUCc1-2) of Mosunetuzumab (Arms A and B)

    Measured: Day 1 - Day 50

  13. Serum Trough Concentration in Cycle 2 (Ctrough, c2) of Mosunetuzumab (Arms A and B)

    Measured: Day 50

  14. AUC at Steady State (AUCss) (Arms A and B)

    Measured: Cycle 4 (cycle length = 28 days)

  15. Percentage of Participants with ADAs to Mosunetuzumab

    Measured: At pre-defined intervals from baseline through follow-up (2 years after last treatment)

Timeline

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

  1. First posted29 Jan 2020
  2. Study start12 Aug 2020
  3. Primary completion6 Sep 2030 (estimated)
  4. Study completion6 Sep 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
237 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246086
Sponsor's protocol ID
CO41942
Other IDs
2019-004291-20, 2019
Status last verified
Sep 2026
First submitted
27 Jan 2020
Last updated
14 Sep 2026
Results posted
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 1/2 study testing Mosunetuzumab (IV), Tocilizumab and Lenalidomide in people with Follicular Lymphoma, run by Hoffmann-La Roche at 26 sites in 5 countries.

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 13 inclusion and 38 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, China, United Kingdom, France, Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Dose-Limiting Toxicities (DLTs) (time frame: Cycle 2 Days 1-28 (cycle length = 28 days)). The study lists 5 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 NCT04246086.

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 14 Sep 2026.

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