Can a bispecific antibody wipe out stubborn CLL cells?
NCT ID NCT07052695
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This pilot study tests whether the drug mosunetuzumab, given alone or with a BTK inhibitor, can clear minimal residual disease (tiny amounts of leftover cancer) in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). About 40 participants who have already been treated with a BTK inhibitor or BCL2 inhibitor will receive the drug combination. The goal is to see if this approach can achieve undetectable MRD in the bone marrow, which may lead to longer remissions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mosunetuzumab (a bispecific antibody) given alone or with a BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib)
- What this could lead to
- If successful, this approach could help people with CLL or SLL achieve deeper remission by clearing leftover cancer cells that standard treatments miss.
- What could go wrong
- This is an early pilot study with only 40 participants, so results may not apply to everyone. Side effects from the immune-activating drug or combination therapy are possible, and the treatment may not work as hoped.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Key Inclusion Criteria: * Meet 2018 iwCLL guidelines for the diagnosis of CLL or SLL * Recent completion of treatment or ongoing treatment for CLL/SLL as follows: * BTKi arm: On continuous BTKi therapy for \> 12 months, including \> 2 months at a stable dose. * BTKis include ibrutinib, acalabrutinib, zanubrutinib and pirtobrutinib. * The BTKi is the first- or second-line therapy for CLL. * BCL2i arm: Completed BCL2i-based therapy \< 12 months of enrollment. * BCL2i-based therapy must be the most recent CLL therapy prior to enrollment. * BCL2i must have been given for at least 6 months for patients who were intolerant to a BCL2i and stopped the treatment without disease progression. For all others, at least 12 cycles of BCL2i therapy are required. * BCL2i-based therapy should have been given as first- or second-line therapy for CLL. * BCL2i-based regimens include venetoclax plus obinutuzumab (VO) or rituximab (VR), and the combination of a BTKi + a BCL2i +/- anti- CD20mAb. * If BCL2i was continued after the combination, the subject is not eligible. * Detectable minimal residual disease (MRD) of ≥10e-4 in peripheral blood (PB) or bone marrow (BM) based on an NGS-based assay. * Age ≥ 18 years * ECOG performance status ≤ 2 * Adequate organ and bone marrow function as defined by the study protocol. * Women of child-bearing potential must agree to remain abstinent or use highly effective contraception during the treatment period and for at least 3 months after the last dose of study therapy and tocilizumab. * Men with female sexual partners of childbearing potential should agree to remain abstinent or use contraceptive measures which include a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 1 month after the last dose of study therapy and 2 months after the last dose of tocilizumab. Men should refrain from donating sperm during the same period. Women should not donate oocytes. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Ability to take oral medications. * Ability to understand and the willingness to sign a written informed consent document. Key Exclusion Criteria: * Bulky disease with any lymph node \> 5cm or absolute lymphocyte count \> 100,000/microliter. * Clinical progression of CLL at the time of enrollment. * Prior treatment with chimeric antigen receptor T-cell therapy within 30 days of starting study therapy, or radioimmunotherapy within 12 weeks of starting study therapy. * History of solid organ or allogeneic stem cell transplantation. * Ongoing significant toxicity (Grade 3 or higher adverse events) from prior BCL2i- or BTKi- -based therapy at the time of enrollment. * Known or suspected Richter's transformation or known CNS involvement of CLL. * History of bleeding disorders (e.g. von Willebrand's disease, hemophilia). * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. * Significant cardiovascular disease such as uncontrolled arrhythmi, class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction \< 40% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment. * Patients with significant pulmonary disease such as uncontrolled obstructive pulmonary disease, history of bronchospasm, uncontrolled idiopathic, autoimmune, or drug-induced interstitial lung disease, or uncontrolled drug induced or auto-immune pneumonitis * Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis * For patients with history of other malignancies with life expectancy of \< 2 years. * Receiving any other investigational agents. * Concurrent systemic immunosuppression (e.g. azathioprine, methotrexate, cyclosporine, tacrolimus, anti-TNF agents, anti-CD20 monoclonal antibody) within 30 days of starting study therapy or administration of \> 20 mg of prednisone or equivalent daily within 14 days of study therapy. * Vaccinated with live vaccine within 4 weeks of starting study therapy. * Major surgery within 4 weeks of starting study therapy. If a subject had major surgery greater than 4 weeks prior to the first dose, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study therapy. * Ongoing or recent infection (e.g. bacterial, viral, fungal, parasitic, or other infection) requiring intravenous antimicrobials within 4 weeks of starting study therapy. Prophylactic antibiotics are allowed if there is no evidence of active infection and the antibiotics is not included on the list of the prohibited medications. * Known or suspected history of hemophagocytic lymphohistiocytosis. * Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab. * Concurrent treatment with warfarin or other vitamin K antagonists for anticoagulation. * Patients who have tested positive for HIV are excluded due to potential drug-drug interactions between anti-retroviral medications and pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment. * Active hepatitis B virus or hepatitis C virus infection * History of progressive multifocal leukoencephalopathy. * Positive SARS-CoV-2 test within 7 days prior to enrollment. * Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment. * Active uncontrolled autoimmune disease. * Significant co-morbid condition or disease which in the judgement of the Principal Investigator would place the patient at undue risk or interfere with the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Brigham & Women's Hospital
RECRUITINGBoston, Massachusetts, 02215, United States
Contact Email: •••••@•••••
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
Contact Email: •••••@•••••
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