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

Last updated: August 1, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1/2

Condition

Follicular Lymphoma

Lymphoproliferative Disorders

Lymphoma

Treatment

Mosunetuzumab (IV)

Tocilizumab

Mosunetuzumab (SC)

Clinical Study ID

NCT04246086
CO41942
2019-004291-20
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 237
Treatment Group(s): 4
Primary Treatment: Mosunetuzumab (IV)
Phase: 1/2
Study Start date:
August 12, 2020
Estimated Completion Date:
October 15, 2030

Connect with a study center

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Hunan Cancer Hospital GCP Pharmacy

    Changsha, 410013
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha CITY, 410013
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha City, 410013
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai City, 200120
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 3000060
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, 300060
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003
    China

    Active - Recruiting

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris, 75475
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud; Direction Générale

    Pierre Benite, 69495
    France

    Site Not Available

  • CHU Rennes - Hopital Pontchaillou

    Rennes cedex 09, 35033
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Institut Claudius Regaud; IUCT Oncopôle

    Toulouse, 31059
    France

    Site Not Available

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

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

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Completed

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Active - Recruiting

  • Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Tennessee Oncology;Chattanooga Oncology & Hematology Associates

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Tennessee Oncology PLLC - Franklin

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center; IDS Pharmacy

    Seattle, Washington 98122
    United States

    Site Not Available

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