Mosunetuzumab for Relapsed or Refractory Chronic Lymphocytic Leukemia
This study is looking at mosunetuzumab (Lunsumio) alone or in combination with venetoclax for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or isn't responding to treatment. Researchers want to see how safe these treatments are, how well they work, and how the body handles them. You might be able to join if you have CLL or SLL that needs treatment and meet certain health criteria, like having good bone marrow function. The study will measure how many people have serious side effects and how many see their cancer shrink or disappear. Some participants currently taking a BTK inhibitor may continue it for a period.
- Study design
- This is an interventional study with a planned enrollment of 332 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures dose-limiting toxicities for up to 12 or 24 months, and objective response rate up to 8-12 weeks after the last dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05091424
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~332 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:MosunetuzumabTocilizumabVenetoclaxRituximab
At a glance
Recruiting sites
24 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Dose-Limiting Toxicities (DLTs)
Measured over Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
+1 more outcome measured
Conditions
Where it's being run
31 sites across 16 statesChina4
Germany3
Lombardy3
Poland3
South Korea3
Victoria2
France2
Spain2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Have a diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek et al 2018)
Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2
Adequate bone marrow (BM) function independent of growth factor or transfusion support, within 2 weeks of screening, at screening as defined by the protocol unless cytopenia is clearly due to marrow involvement of CLL
Adequate liver function unless directly attributable to the participant's CLL
Life expectancy \> 6 months
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year, and agreement to refrain from donating eggs during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm as defined by the protocol
Participants must have been taking a BTKi for at least 12 months, have demonstrated evidence of progressive disease while receiving the BTKi and require additional salvage therapy as assessed by their treating physician. Participants should be able to continue their previously prescribed BTKi at a stable dose throughout the study screening period and for up to three cycles of mosunetuzumab administration
Non-US participants only
Exclusion
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab or within 30 days after the final dose of venetoclax (if applicable)
Participants who have received any of the following treatments prior to study entry: treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies; allogenic stem cell transplant
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; autologous stem cell transplant within 100 days prior to first study treatment; CAR T-cell therapy within 30 days before first study treatment; prior use of any monoclonal antibodies, radioimmunoconjugates, or antibody-drug conjugates for anti-CLL treatment within 4 weeks before first dose of study treatment; systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of study treatment; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy within 4 weeks prior to initiation of study treatment (except for participants enrolled in Arm B, where overlapping therapy is permitted; other prior cancer immunotherapy not explicitly defined by the protocol is to be discussed with the medical monitor to determine eligibility
Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a vaccine will be required during the study period or within 5 months after the final dose of study treatment
Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL)
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Contraindication to tocilizumab
History of prior malignancy except for conditions defined by the protocol
Participants with infections requiring intravenous (IV) treatment with antibiotics or hospitalization 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
Evidence of any significant concomitant disease that could affect compliance with the protocol or interpretation of results
Recent major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
Positive SARS-CoV-2 test within 7 days prior to enrollment
Have received venetoclax therapy within 12 months prior to first study treatment administration
Participants with known infection with HIV or human T-cell leukemia virus 1 (HTLV1)
HIV testing will be performed in countries where mandatory testing by health authorities is required
HTLV testing is required in participants from endemic countries
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Participants who have received the following: strong and moderate CYP3A inhibitors within 7 days prior to the initiation of study treatment; strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment; steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration
Have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration
Inability to swallow a large number of tablets
Malabsorption syndrome or other condition that precludes enteral route of administration
Known allergy to both xanthine oxidase inhibitors and rasburicase
What this trial measures
- Rate of Dose-Limiting Toxicities (DLTs)Up to approximately 12 months (Arms A and B) or 24 months (Arm C)
- Objective Response Rate (ORR) During Dose Expansion PhaseUp to 8-12 weeks after the last dose of study drug