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NCT04246086Active, not recruitingPhase 1/2

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 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

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
237 (estimated)
First submitted
27 Jan 2020
Start date
12 Aug 2020
Primary completion date
6 Sept 2030
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04246086
EU CT number
2023-507236-20-00
EudraCT number
2019-004291-20

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 237
  • From 12 Aug 2020 to the primary completion date, 6 Sept 2030
  • 32 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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 erythema multiforme, Grade \>=3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • 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
  • Prior allogenic hematopoietic stem cell transplant
  • 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
  • Prior allogenic hematopoietic stem cell transplant (HSCT)
  • 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
  • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment

Other illness

  • Any history of Grade 3b FL
  • Any history of disease transformation and/or diffuse large B-cell lymphoma (DLBCL)
  • Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
  • 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
  • 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
  • Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
  • 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
  • Known history of HIV positive status
  • History of progressive multifocal leukoencephalopathy
  • Other malignancy that could affect compliance with the protocol or interpretation of results
  • Contraindication to treatment for thromboembolism prophylaxis
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Lab values

  • Any of the following abnormal laboratory values
  • 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

Other

  • Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment
  • Documented refractoriness to an obinutuzumab monotherapy containing regimen in glofitamab-containing treatment combination
  • Grade \>=2 neuropathy
  • Inadequate hematologic function
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjingChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceActive, not recruiting
University College London Hospitals NHS Foundation Trust - University College Hospital
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust - City Hospital
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NottinghamUnited KingdomUnknown status
University Of Michigan Comprehensive Cancer Center
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Ann ArborUnited StatesUnknown status
Mary Bird Perkins Cancer Ctr
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Baton RougeUnited StatesUnknown status
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
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ChattanoogaUnited StatesUnknown status
Fairview Hospital
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ClevelandUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Tennessee Oncology, PLLC - Franklin
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FranklinUnited StatesUnknown status
Norton Cancer Institute St. Matthews
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LouisvilleUnited StatesUnknown status
Hillcrest Hospital
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Mayfield HeightsUnited StatesUnknown status
University of Miami Miller School of Medicine
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MiamiUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
Rhode Island Hematology/Oncology Program
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WoonsocketUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.