Phase 2 Study of Mosunetuzumab for Chronic Lymphocytic Leukemia
This study is testing a drug called mosunetuzumab in people with chronic lymphocytic leukemia (CLL) who still have signs of the disease after taking other treatments called BTK inhibitors for at least six months. Mosunetuzumab is a bispecific antibody, meaning it can target two specific things in the body. The main goal is to see how well mosunetuzumab, when added to ongoing BTK inhibitor therapy, can eliminate minimal residual disease (MRD), which are very small numbers of cancer cells. Researchers hope that 50% of participants will have undetectable MRD in their bone marrow after about 17 cycles of mosunetuzumab treatment. You may be able to join if you are 18 or older and have received at least two prior treatments for CLL, including a BTK inhibitor. This study is currently recruiting about 30 participants, but its overall status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is a Phase 2 study, which means it's looking at how well the treatment works and its safety.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and side effects will be monitored throughout the study, which is expected to last an average of one year. MRD status will also be assessed every 6 months for 3 years after the combined treatment ends.
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NCT07566364
Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Mosunetuzumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Mahesh Swaminathan, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Platelet count ≥50,000/µL; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be
ANC ≥1.5x109 cells/L unless neutropenia is clearly due to marrow involvement of CLL (per the discretion of the investigator)
Total hemoglobin ≥10 g/dL unless anemia is due to marrow involvement of CLL (per the discretion of the investigator) h. Adequate liver function as indicated by a total bilirubin ≤1.5 x ULN, AST, and ALT ≤3 times the institutional ULN value
In patients with CLL involvement of the liver; AST and ALT \<5 times institutional ULN and total bilirubin \<3 times institutional ULN i. In patients with Gilbert syndrome: total bilirubin \<3 times institutional ULN j. Adequate renal function: serum creatinine ≤1.5 ULN or eGFR ≥50 mL/min k. Life expectancy \>6 months l. Resolution to Grade ≤1 for clinically significant toxicities attributable to prior therapies before commencement of the first study drug administration with the following exceptions:
Any grade alopecia or vitiligo
Grade 2 peripheral sensory or motor neuropathy
Endocrinopathy managed and controlled using replacement therapy m. Patients who have a negative HIV test at screening, with the following exception.
Patients with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/μL, have an undetectable viral load, and have not had a history of an AIDSdefining opportunistic infection within the past 12 months.
With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 2 months after the final dose of tocilizumab (if applicable), to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual.
Exclusion
Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
Allogeneic stem cell transplant within 90 days of enrollment or with active GVHD c. Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:
Radiotherapy within 2 weeks prior to the first dose of study treatment
CAR T-cell therapy within 90 days before first study treatment
Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment d. Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment
Systemic corticosteroid treatment ≤25 mg/day prednisone or equivalent and inhaled corticosteroids are permitted.
Administration of acute, low-dose, systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B-symptoms) is permitted.
The use of mineralocorticoids for management of orthostatic hypotension and corticosteroids for management of adrenal insufficiency is permitted. e. Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment. f. Prior cancer immunotherapy not explicitly described in this protocol g. Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment h. Transformation of CLL to aggressive NHL (e.g., Richter's transformation, prolymphocytic leukemia, or diffuse large B-cell lymphoma \[DLBCL\]) or CNS involvement by CLL i. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) j. History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:
Malignancies treated with curative intent and with no known active disease present for ≥2 years before enrollment
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Surgically/adequately treated low grade, early stage, localized prostate cancer without evidence of disease k. Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment l. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:
Significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)
Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort m. History of confirmed progressive multifocal leukoencephalopathy (PML) n. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology)
Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening.
These participants must be willing to undergo monthly DNA testing and appropriate prophylactic antiviral therapy as indicated. o. Acute or chronic hepatitis C virus (HCV) infection
Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation. p. Known or suspected chronic active Epstein-Barr virus infection q. Known or suspected history of HLH r. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.
Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review by the investigator. s. Evidence of other clinically significant uncontrolled condition(s) including but not limited to active or uncontrolled systemic infections (e.g., viral, bacterial, or fungal) t. Recent major surgery within 4 weeks prior to first study treatment administration, except for protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies) u. Participants with a left ventricular ejection fraction (LVEF) \<40% v. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
What this trial measures
- Safety and Adverse Events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0