Actively Recruiting
A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of four drugs—mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide—in adults with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL), types of B-cell non-Hodgkin lymphoma (NHL). This phase II trial aims to determine the safety of this drug combination and measure how well it helps control the disease by assessing response rates and survival outcomes. The study will also explore changes in immune cells and the tumor environment after treatment. The trial includes a safety run-in phase where the tolerable doses of the four drugs are tested. Afterward, participants receive the established dose level in the dose expansion phase. Mosunetuzumab, polatuzumab vedotin, and tafasitamab are given intravenously (through a vein), while lenalidomide is taken orally. The study groups involve participants receiving these drugs in combination as experimental treatment. The treatment schedule and dosing are based on findings from the safety testing phase. Participants will be closely monitored during the study with assessments to track treatment response and safety. The primary outcome measured is the best overall response rate over approximately one year. Researchers will evaluate effects on disease control and survival, as well as immune system changes. Participants must agree to various safety measures, including contraception and blood tests, and will be followed through the study duration until completion around 2027.
CONDITIONS
Brief Title
A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed CD20-positive follicular lymphoma grade 1-3a or relapsed CD20-positive diffuse large B-cell lymphoma
- Evidence of disease progression or lack of response after at least one prior treatment
- Age 18 years or older
- At least one measurable tumor site greater than 1.5 cm
- Adequate blood counts: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 75 x 10^9/L
- Liver function within specified limits unless related to Gilbert's syndrome
- Creatinine clearance ≥ 30 ml/min (dose adjustments apply if between 30 and 60 ml/min)
- Willingness to receive blood transfusions if needed
- For men, agreement to use barrier contraception and ensure partner contraception for specified periods
- For women of childbearing potential, use of two effective contraception methods for 12 months after last dose
- Negative pregnancy tests as required and commitment to ongoing pregnancy testing
- Enrollment in the Revlimid REMS program and willingness to comply
- Ability to take daily aspirin or alternative anticoagulation as prophylaxis
- Willingness and ability to comply with study protocol and provide informed consent
You will not qualify if you...
- Known allergy to any study drug
- Prior treatment with polatuzumab vedotin, mosunetuzumab, tafasitamab, or lenalidomide
- Recent autologous or allogeneic stem cell transplant or CAR-T therapy within specified timeframes
- Eligibility for autologous stem cell transplant for relapsed/refractory DLBCL
- History of solid organ transplant
- Severe allergic reactions to monoclonal antibody therapy
- Use of systemic immunosuppressive medications or corticosteroids above specified doses recently
- Recent chemotherapy or radiotherapy within specified timeframes
- History of other cancers within last two years except certain skin or cervical cancers
- Serious medical conditions or lab abnormalities that increase risk or interfere with study
- Active infections including HIV, hepatitis B or C, tuberculosis, or Epstein-Barr virus
- Recent live vaccinations
- Peripheral neuropathy grade 2 or higher
- Pregnant or breastfeeding women
- Central nervous system lymphoma involvement
- Contraindications to required supportive treatments
- Recent pulmonary embolism or deep vein thrombosis
- Recent major surgery or unhealed wounds
- Recent stroke or bleeding disorders
- Uncontrolled autoimmune diseases
- Participation in another therapeutic clinical trial concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide as part of the study treatment.
Multiple visits for infusions and assessments during treatment
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Westin, MD, MS, FACP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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