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LeukemiaPhase 1/2NCT07052695

Mosunetuzumab for CLL MRD Clearance

A Phase 1/2 study testing Mosunetuzumab, Ibrutinib and Acalabrutinib in people with Leukemia and Chronic Lymphocytic Leukemia, run by Inhye Ahn at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab, Ibrutinib and Acalabrutinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
24 Nov 2025to 31 Dec 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

DFCI Clinical Trials Hotline contact

877-DF-TRIAL

DFCILymphomaResearchNurses@partners.org

United States2 sites, 2 recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02215

    Inhye Ahn, MD, 877-DF-TRIAL, DFCILymphomaResearchNurses@partners.org

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Inhye Ahn, MD, 877-DF-TRIAL, DFCILymphomaResearchNurses@partners.org

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study Evaluating Mosunetuzumab for Clearance of Detectable Minimal Residual Disease in Chronic Lymphocytic Leukemia

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
Read the detailed description

This is open-label, multicenter, pilot study of mosunetuzumab given alone or in combination with a BTKi in participants with CLL/SLL. Participants who are already taking a BTKi will continue the BTKi while receiving Mosunetuzumab on this study. Participants who have been previously treated with a drug called B-cell lymphoma 2 inhibitor (BCL2i) will receive Mosunetuzumab alone. Treatment with mosunetuzumab is given up to 17 cycles (approximately 1 year). Patients who achieve early MRD clearance will stop mosutuzumab after 8 cycles (approximately 6 months).

Being tested
Mosunetuzumab, Ibrutinib, Acalabrutinib, Zanubrutinib, Pirtobrutinib
Keywords
Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoma
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MosunetuzumabDrug

    Subcutaneous injection of a CD20xCD3 bispecific antibody

  • IbrutinibDrug

    For participants who have been ibrutinib PO prior to enrollment

  • AcalabrutinibDrug

    For participants who have been acalabrutinib PO prior to enrollment

  • ZanubrutinibDrug

    For participants who have been zanubrutinib PO prior to enrollment

  • PirtobrutinibDrug

    For participants who have been pirtobrutinib PO prior to enrollment

Study groups in NCT07052695
Study groupRoleWhat they receive
BCL2i armExperimental20 enrolled participants who have been previously treated with a BCL2i-containing regimen will receive up to 17 cycles of mosunetuzumab
Receives: Drug: Mosunetuzumab
BTKi armExperimental20 enrolled participants who have been on a BTKi will receive up to 17 cycles of mosunetuzumab. Each participant will continue the BTKi during treatment with mosunetuzumab.
Receives: Drug: Mosunetuzumab; Drug: Ibrutinib; Drug: Acalabrutinib; Drug: Zanubrutinib; Drug: Pirtobrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of undetectable bone marrow minimal residual disease

    Undetectable bone marrow minimal residual disease (MRD) is defined by < 1 CLL cell in 10,000 leukocytes (uMRD4) using an NGS-based assay at any time during C8 through C17 of mosunetuzumab.

    Measured: Up to 1 year

Secondary outcomes (2)

  1. Safety of mosunetuzumab

    Adverse events

    Measured: Up to 30 days after the last dose of mosunetuzumab.

  2. Efficacy of mosunetuzumab

    Complete, partial, and overall responses based on the International Workshop on CLL guidelines, 3-year progression-free survival, 3-year time-to-next-treatment, 3-year treatment-free survival, 3-year overall survival

    Measured: 3 years from the initiation of study therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2025
  2. Study start24 Nov 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052695
Sponsor's protocol ID
25-277
Status last verified
Dec 2025
First submitted
28 Jun 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mosunetuzumab, Ibrutinib and Acalabrutinib in people with Leukemia and Chronic Lymphocytic Leukemia, run by Inhye Ahn at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DFCI Clinical Trials Hotline (877-DF-TRIAL, DFCILymphomaResearchNurses@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of undetectable bone marrow minimal residual disease (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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