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Active, not recruitingNCT04246086Updated Sep 14, 2026

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 interventional study of Mosunetuzumab (IV) and Tocilizumab in Follicular Lymphoma, sponsored by Hoffmann-La Roche. Active, not recruiting at 26 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Follicular Lymphoma

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03

In context

Lymphoma, Follicular

932 studies on the registry are indexed under Lymphoma, Follicular; 236 are open to participants now.

This study's planned enrollment of 237 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.

Browse Lymphoma, Follicular studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
237 participants (estimated)

Study arms

  • 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) · Drug: Tocilizumab · Drug: Lenalidomide

  • 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 · Drug: Lenalidomide

  • 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) · Drug: Lenalidomide

  • 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 · Drug: Mosunetuzumab (SC)

Interventions

  • DrugMosunetuzumab (IV)

    Participants will receive IV mosunetuzumab as defined by the study protocol

    Also known as: RO7030816

  • DrugTocilizumab

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

    Also known as: RO4877533

  • DrugLenalidomide

    Participants will receive oral lenalidomide as defined by the study protocol

  • DrugMosunetuzumab (SC)

    Participants will receive SC mosunetuzumab as defined by the study protocol

    Also known as: RO7030816

06

What researchers measure

Primary outcomes

  1. Dose-Limiting Toxicities (DLTs)

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

  2. Percentage of Participants with Adverse Events

    Time frame: 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

    Time frame: Day 1 - Day 78

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

    Time frame: Day 106

  5. 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)

Secondary outcomes

  1. 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)

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

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

  3. 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)

  4. ORR as determined by IRC (randomized stage)

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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

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

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

  10. 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)

  11. 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)

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

    Time frame: Day 1 - Day 50

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

    Time frame: Day 50

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

    Time frame: Cycle 4 (cycle length = 28 days)

  15. Percentage of Participants with ADAs to Mosunetuzumab

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

07

Study locations

26 sites
  • City of Hope National Medical Center
    Duarte, California 91010, United States
  • University of Miami Miller School of Medicine
    Miami, Florida 33136-1002, United States
  • Norton Cancer Institute - St. Matthews
    Louisville, Kentucky 40207-4723, United States
  • Mary Bird Perkins Cancer Ctr
    Baton Rouge, Louisiana 70809, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Duke University Medical Center
    Durham, North Carolina 27710-4000, United States
  • Fairview Hospital
    Cleveland, Ohio 44111, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195-0001, United States
  • Hillcrest Hospital
    Mayfield Heights, Ohio 44124, United States
  • Rhode Island Hematology/Oncology Program
    Woonsocket, Rhode Island 02895-4720, United States
  • Tennessee Oncology;Chattanooga Oncology & Hematology Associates
    Chattanooga, Tennessee 37404, United States
  • Tennessee Oncology PLLC - Franklin
    Franklin, Tennessee 37067, United States
  • Swedish Medical Center
    Seattle, Washington 98122, United States
  • The First Hospital of Jilin University
    Changchun, 130021, China
  • West China Hospital, Sichuan University
    Chengdu, 610041, China
  • Fudan University Shanghai Cancer Center
    Shanghai, 200120, China
  • Tianjin Medical University Cancer Institute & Hospital
    Tianjing, 300060, China
  • The First Affiliated Hospital of Xiamen University
    Xiamen, 361003, China
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69495, France
  • CHU Rennes - Hopital Pontchaillou
    Rennes, 35033, France
  • Hospital Universitario Fundacion Jimenez Diaz.
    Madrid, 28040, Spain
  • Hospital Universitario Virgen de la Victoria
    Málaga, 29010, Spain
  • University College London Hospitals NHS Foundation Trust - University College Hospital
    London, NW1 2PG, United Kingdom
  • The Christie NHS Foundation Trust
    Manchester, M20 4BX, United Kingdom
  • Freeman Hospital
    Newcastle upon Tyne, NE7 7DN, United Kingdom
  • Nottingham University Hospitals NHS Trust - City Hospital
    Nottingham, NG5 1PB, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04246086
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 29, 2020
Start date
Aug 12, 2020
Primary completion
Sep 6, 2030 (estimated)
Completion
Sep 6, 2030 (estimated)
Last update
Sep 14, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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