Actively Recruiting
Mosunetuzumab for CLL MRD Clearance
Led by Inhye Ahn · Updated on 2025-12-15
40
Participants Needed
2
Research Sites
370 weeks
Total Duration
On this page
Sponsors
I
Inhye Ahn
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to test mosunetuzumab given alone or in combination with a Bruton tyrosine kinase inhibitor (BTKi, such as ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) in participants with CLL (chronic lymphocytic leukemia) or small lymphocytic lymphoma (SLL). The names of the study drugs in this research study are: * Mosunetuzumab * BTK inhibitor: Ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib
CONDITIONS
Official Title
Mosunetuzumab for CLL MRD Clearance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to 2018 iwCLL guidelines
- Currently on continuous Bruton tyrosine kinase inhibitor (BTKi) therapy for more than 12 months with at least 2 months at stable dose, or completed B-cell lymphoma 2 inhibitor (BCL2i) therapy less than 12 months before enrollment
- Detectable minimal residual disease (MRD) of at least 10^-4 in peripheral blood or bone marrow
- Age 18 years or older
- ECOG performance status of 2 or less
- Adequate organ and bone marrow function as defined by the study protocol
- Women of child-bearing potential agree to abstinence or use highly effective contraception during and for 3 months after treatment
- Men with female partners of childbearing potential agree to abstinence or use effective contraception during and for 1 month after treatment, and refrain from sperm donation during this time
- Ability to take oral medications
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Bulky disease with any lymph node larger than 5 cm or absolute lymphocyte count over 100,000/microliter
- Clinical progression of CLL at enrollment
- Prior chimeric antigen receptor T-cell therapy within 30 days or radioimmunotherapy within 12 weeks before study therapy
- History of solid organ or allogeneic stem cell transplant
- Ongoing severe toxicity (Grade 3 or higher) from prior BCL2i- or BTKi-based therapy
- Known or suspected Richter's transformation or CNS involvement of CLL
- History of bleeding disorders such as von Willebrand's disease or hemophilia
- Current or past central nervous system disease like stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Significant cardiovascular disease including uncontrolled arrhythmia, severe heart failure, low ejection fraction, unstable angina, or recent myocardial infarction
- Significant pulmonary disease such as uncontrolled obstructive pulmonary disease or interstitial lung disease
- Clinically significant liver disease including hepatitis or cirrhosis
- History of other malignancies with life expectancy under 2 years
- Receiving other investigational agents
- Concurrent systemic immunosuppression or high-dose prednisone use within specified timeframes
- Recent live vaccination or major surgery within 4 weeks before study therapy
- Ongoing or recent serious infection requiring intravenous antibiotics within 4 weeks before study therapy
- Known or suspected hemophagocytic lymphohistiocytosis
- Known allergy to mosunetuzumab or components
- Concurrent treatment with warfarin or vitamin K antagonists
- Positive HIV test or active hepatitis B or C infection
- History of progressive multifocal leukoencephalopathy
- Positive SARS-CoV-2 test within 7 days before enrollment
- Pregnancy, breastfeeding, or planning pregnancy within 6 months of last dose
- Active uncontrolled autoimmune disease
- Other significant medical conditions posing undue risk or interfering with the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
D
DFCI Clinical Trials Hotline
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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