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Study identifier: NCT05091424 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma  ·  Sponsor: Hoffmann-La Roche

PhasePhase 1
Planned participants332
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first three cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (31)

Mayo Clinic RochesterRochester, Minnesota, United StatesRecruiting
Memorial Sloan-Kettering Cancer CenterNew York, New York, United StatesWithdrawn
The James Cancer Hospital and Solove Research InstituteColumbus, Ohio, United StatesRecruiting
Uni of Texas - Md Anderson Cancer CenterHouston, Texas, United StatesWithdrawn
Huntsman Cancer Institute at The University of UtahSalt Lake City, Utah, United StatesRecruiting
Princess Alexandra Hospital WoolloongabbaWoolloongabba, Queensland, AustraliaRecruiting
Peter MacCallum Cancer CenterEast Melbourne, Victoria, AustraliaCompleted
Monash Medical CentreMelbourne, Victoria, AustraliaRecruiting
Peking University People's HospitalBeijing, ChinaRecruiting
Southern Medical University Nanfang HospitalGuangzhou, ChinaRecruiting
The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting
Tianjin Institute of Hematology & Blood Diseases HospitalTianjin, ChinaRecruiting

+ 19 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05091424