🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04246086
Active, not recruiting Phase 1/Phase 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

NCT04246086 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1/Phase 2
Started
2020-08-12
Last updated
2026-09-14

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

Mosunetuzumab (IV)TocilizumabLenalidomideMosunetuzumab (SC)

Mosunetuzumab (IV): Participants will receive IV mosunetuzumab as defined by the study protocol

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

Lenalidomide: Participants will receive oral lenalidomide as defined by the study protocol

Mosunetuzumab (SC): Participants will receive SC mosunetuzumab as defined by the study protocol

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

Sex
ALL
Min age
18 Years
Max age
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 * 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

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
University of Miami Miller School of Medicine Miami Florida
Norton Cancer Institute - St. Matthews Louisville Kentucky
Mary Bird Perkins Cancer Ctr Baton Rouge Louisiana
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
Duke University Medical Center Durham North Carolina
Fairview Hospital Cleveland Ohio
Cleveland Clinic Cleveland Ohio
Hillcrest Hospital Mayfield Heights Ohio
Rhode Island Hematology/Oncology Program Woonsocket Rhode Island
Tennessee Oncology;Chattanooga Oncology & Hematology Associates Chattanooga Tennessee
Tennessee Oncology PLLC - Franklin Franklin Tennessee
Swedish Medical Center Seattle Washington
The First Hospital of Jilin University Changchun China
West China Hospital, Sichuan University Chengdu China
Fudan University Shanghai Cancer Center Shanghai China
Tianjin Medical University Cancer Institute & Hospital Tianjing China
The First Affiliated Hospital of Xiamen University Xiamen China
Centre Hospitalier Lyon Sud Pierre-Bénite France
CHU Rennes - Hopital Pontchaillou Rennes France
Hospital Universitario Fundacion Jimenez Diaz. Madrid Spain
Hospital Universitario Virgen de la Victoria Málaga Spain
University College London Hospitals NHS Foundation Trust - University College Hospital London United Kingdom
The Christie NHS Foundation Trust Manchester United Kingdom
Freeman Hospital Newcastle upon Tyne United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital Nottingham United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04246086 on ClinicalTrials.gov ↗ ← All trials in the UK