Actively Recruiting
Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma
Led by City of Hope Medical Center · Updated on 2025-09-24
41
Participants Needed
2
Research Sites
183 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.
CONDITIONS
Official Title
Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if appropriate
- Willing to provide tumor tissue from a recent or diagnostic biopsy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Histologically confirmed follicular lymphoma grade 1-3a
- Relapsed or refractory disease after at least one prior therapy confirmed by biopsy
- Tumor positive for CD20 after most recent therapy
- Active disease needing treatment as decided by treating physician
- Measurable disease by Lugano criteria with nodal or extranodal lesions
- Recovered from acute toxic effects of prior therapy to grade 1 or less (except alopecia)
- Specific blood count requirements depending on bone marrow involvement
- Hemoglobin level at least 8 g/dL
- Liver enzymes and bilirubin within defined limits
- Creatinine clearance of at least 40 mL/min
- Coagulation tests within specified ranges depending on anticoagulant use
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception or abstinence during and after treatment periods
You will not qualify if you...
- Prior treatment with mosunetuzumab or CD20-directed bispecific antibodies with resistance, or more than 2 doses
- Prior treatment with polatuzumab vedotin or similar antibody-drug conjugates with resistance, or more than 2 doses
- Allogeneic stem cell transplant within 2 years or with active complications
- Autologous stem cell transplant within 100 days before treatment
- CAR-T therapy within 30 days before treatment
- Recent anti-lymphoma or chemotherapy treatment within specified timeframes
- Radiotherapy within 2 weeks before treatment unless specific conditions met
- Live vaccine within 30 days before treatment
- Ongoing systemic immunosuppressive therapy except limited corticosteroid use
- Grade 2 or higher peripheral neuropathy
- History of severe allergic reactions to monoclonal antibodies
- Solid organ transplant history
- History of progressive multifocal leukoencephalopathy
- Known or suspected hemophagocytic lymphohistiocytosis
- Significant active pulmonary disease or pneumonitis requiring treatment
- Positive SARS-CoV-2 test within 7 days before treatment
- Uncontrolled illness or active infections requiring treatment
- Active hepatitis B, C, or uncontrolled HIV infection
- Active or suspected chronic Epstein-Barr virus infection
- Active central nervous system lymphoma involvement
- Recent symptomatic CNS disease or stroke
- Severe cardiac disease or recent cardiovascular events
- Significant liver disease
- Active autoimmune disease requiring systemic treatment
- Recent major surgery within 4 weeks
- Other primary malignancy not in remission for at least 2 years with exceptions
- Concurrent investigational therapy or within 7 days before study
- Pregnant or breastfeeding females
- Any condition or situation that could interfere with study participation or safety as judged by the investigator
- Inability to comply with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Not Yet Recruiting
Research Team
M
Matthew Mei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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