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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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT04246086•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more 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
+28 more criteria

Locations (26)

City of Hope National Medical Center

Duarte, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Norton Cancer Institute - St. Matthews

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Ctr

Baton Rouge, Louisiana, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hillcrest Hospital

Mayfield Heights, Ohio, United States

Rhode Island Hematology/Oncology Program

Woonsocket, Rhode Island, United States

Key Dates

Start Date

August 12, 2020

Primary Completion Date

September 6, 2030

Completion Date

September 6, 2030

Last Updated

March 19, 2026

Enrollment

237

ESTIMATED participants

Conditions

Follicular Lymphoma

Interventions

Mosunetuzumab (IV)

DRUG

Tocilizumab

DRUG

Lenalidomide

DRUG

Mosunetuzumab (SC)

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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