New combo shot could tame follicular lymphoma
NCT ID NCT04246086
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This study tests two drugs, mosunetuzumab and lenalidomide, together in people with follicular lymphoma, a type of blood cancer. It includes 237 participants and compares giving one drug as a shot under the skin versus through an IV. The goal is to see if the combination is safe and works better at controlling the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mosunetuzumab and lenalidomide
- What this could lead to
- If successful, this combination could offer a new treatment option for people with follicular lymphoma, potentially improving response rates and convenience with a subcutaneous injection.
- What could go wrong
- This is an early-phase trial (phase 1/2) with a small number of participants, so results may not confirm safety or effectiveness. Side effects from the drugs could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 237 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Rennes - Hopital Pontchaillou
Rennes, 35033, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Cleveland Clinic
Cleveland, Ohio, 44195-0001, United States
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Duke University Medical Center
Durham, North Carolina, 27710-4000, United States
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Fairview Hospital
Cleveland, Ohio, 44111, United States
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Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
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Fudan University Shanghai Cancer Center
Shanghai, 200120, China
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Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
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Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040, Spain
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Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
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Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, 70809, United States
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Norton Cancer Institute - St. Matthews
Louisville, Kentucky, 40207-4723, United States
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Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB, United Kingdom
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Rhode Island Hematology/Oncology Program
Woonsocket, Rhode Island, 02895-4720, United States
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Swedish Medical Center
Seattle, Washington, 98122, United States
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Tennessee Oncology PLLC - Franklin
Franklin, Tennessee, 37067, United States
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Tennessee Oncology;Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, 37404, United States
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The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
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The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
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The First Hospital of Jilin University
Changchun, 130021, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjing, 300060, China
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University College London Hospitals NHS Foundation Trust - University College Hospital
London, NW1 2PG, United Kingdom
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University of Miami Miller School of Medicine
Miami, Florida, 33136-1002, United States
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
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West China Hospital, Sichuan University
Chengdu, 610041, China
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- Can a Triple-Drug combo wipe out Slow-Growing lymphomas?