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
NCT ID: NCT05091424
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
137 participants
INTERVENTIONAL
2022-03-07
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy
Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab
Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Arm B
Participants with R/R CLL who have failed two prior lines of therapy, who are currently progressing on BTKi therapy, and who require salvage therapy as assessed by their treating physician will receive mosunetuzumab SC with BTKi overlap therapy for the first two cycles of mosunetuzumab SC
Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab
Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Arm C (non-US participants only)
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax (this arm is open only to participants outside of the US)
Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab
Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Venetoclax
Participants will receive daily oral venetoclax
Interventions
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Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab
Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Venetoclax
Participants will receive daily oral venetoclax
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 the first two cycles of mosunetuzumab administration
* Non-US participants only
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Uni of Texas - Md Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Center
East Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Southern Medical University Nanfang Hospital
Guangzhou, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Chu de Clermont Ferrand
Clermont-Ferrand, , France
IUCT Oncopole
Toulouse, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Uniklinik Koln
Cologne, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy
Osp. San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Sant'Andrea Delle Fratte (PG), Umbria, Italy
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
PRATIA MCM Kraków
Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Yeouido St. Mary's Hospital
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Christie Hospital NHS Trust
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BO43243 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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BO43243
Identifier Type: -
Identifier Source: org_study_id