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
- Diseases
- Follicular lymphoma
- 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
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjing | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| University College London Hospitals NHS Foundation Trust - University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust - City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Mary Bird Perkins Cancer Ctr Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Tennessee Oncology - Chattanooga Oncology & Hematology Associates Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Fairview Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Tennessee Oncology, PLLC - Franklin Coordinator of this site? Confirm its status | Franklin | United States | Unknown status |
| Norton Cancer Institute St. Matthews Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Hillcrest Hospital Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Rhode Island Hematology/Oncology Program Coordinator of this site? Confirm its status | Woonsocket | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.