Testing Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for Relapsed/Refractory DLBCL
This study is testing a combination of three anti-cancer drugs: mosunetuzumab, polatuzumab vedotin, and lenalidomide. It's for people with diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments. The main goal is to find the safest and most effective dose of these drugs together. Researchers will also look at how well this combination fights the cancer. You might be able to join if you are 18 or older and have certain types of DLBCL that have relapsed or are refractory after at least one prior treatment. The study is currently unclear on its recruitment status and plans to enroll about 30 participants.
- Study design
- This is a Phase 1 study, starting with a dose-escalation phase to find the best dose, followed by a dose-expansion phase. It aims to enroll about 30 participants.
- What's involved
- You would undergo blood sample collection and PET/CT scans. You would receive lenalidomide by mouth and mosunetuzumab and polatuzumab vedotin through an IV.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be measured during the first 28-day cycle of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06015880
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~30 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyLenalidomideMosunetuzumabPolatuzumab VedotinPositron Emission Tomography
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of monsunetuzumab+polatuzumab vedotin+lenalidomide for determination of recommended phase 2 dose
Measured over During cycle 1 (cycle=28 days)
Conditions
NCT06015880
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Case Western Reserve University
Cleveland, Ohiostudy coordinator listed
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, Californiastudy coordinator listed
Recruiting
Moffitt Cancer Center
Tampa, Floridastudy coordinator listed
Recruiting
Northwestern University
Chicago, Illinoisstudy coordinator listed
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, Californiastudy coordinator listed
Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahomastudy coordinator listed
Recruiting
University of Virginia Cancer Center
Charlottesville, Virginiastudy coordinator listed
Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Joseph M Tuscano · PRINCIPAL_INVESTIGATOR · City of Hope Comprehensive Cancer Center LAO
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma as per the World Health Organization 2022 criteria
All patients will have relapsed/refractory DLBCL after 1 or more prior lines of therapy with the exception of patients receiving CAR T in second line that have a D score of 3 at day (D)+ 30 through D+ 90
Patients who progressed/relapsed after prior polatuzumab vedotin are allowed
For the expansion cohorts only: cohort A must have Deauville score of ≥ 3 with the first 90 days) after standard of care chimeric antigen receptor (CAR) T-cell therapy; cohort B- other patients with relapsed/refractory after 1 or more prior lines of therapy (e.g. relapse after Day 90 from CAR-T, or relapsed after other therapies and were not considered candidates for CAR-T)
All patients that have failed 1 line of therapy will be eligible with the exception of a 12 patient cohort (A) that will require prior CAR T therapy
Measurable disease by CT or PET scan, with one or more sites of disease \>= 1.5 cm in longest dimension
Age \>= 18 years
Because no dosing or adverse event data are currently available on the use of mosunetuzumab in combination with polatuzumab vedotin, and lenalidomide in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
Life expectancy \>= 12 weeks
Absolute neutrophil count \>= 1,000/mcL
Platelets \>= 50,000/mcL without transfusion for 2 weeks prior to cycle 1 day 1 (C1D1)
Hemoglobin \>= 9 g/dL
Total bilirubin =\< 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 × ULN may be enrolled)
Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 × ULN (AST and/or ALT =\< 5 × ULN for patients with liver involvement)
Alkaline phosphatase =\< 2.5 × ULN (=\< 5 × ULN for patients with documented liver involvement or bone metastases)
Creatinine clearance \>= 30 mL/min/1.73 m\^2 by Cockcroft-Gault: (140- age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg/dL)
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =\< 1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging 6-8 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression or CNS lymphoma
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of 1% per year during the treatment period and for 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
With female partners of childbearing potential, men must remain abstinent or use a condom during the treatment period, 5 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide
Some concurrent cancer therapeutics (e.g., prostate, breast hormonal-based therapy) are allowed
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Agree to comply with all local requirements of the lenalidomide risk minimization plan
Exclusion
Plasmablastic lymphoma, primary mediastinal B-cell lymphoma, gray zone lymphoma
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who are receiving any other investigational agents or treatments
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or other agents used in study
Patients with uncontrolled intercurrent illness
Uncontrolled or known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first study treatment administration
Active CNS involvement or detectable disease by lymphoma, including leptomeningeal involvement
Pregnant women are excluded from this study because mosunetuzumab is bispecific antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mosunetuzumab, breastfeeding should be discontinued if the mother is treated with mosunetuzumab. These potential risks may also apply to other agents used in this study. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the final dose of lenalidomide
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Patients with any other significant condition(s) that would make this protocol unreasonably hazardous
Current \> grade 1 peripheral neuropathy
Prior solid organ transplantation
Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
Currently active or uncontrolled autoimmune disease
Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible
What this trial measures
- Safety and tolerability of monsunetuzumab+polatuzumab vedotin+lenalidomide for determination of recommended phase 2 doseDuring cycle 1 (cycle=28 days)
Dose limiting toxicity will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.