🏛️ Verified NIH Record • Updated 2026-08-03
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 (NCT05091424)
🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (23 items).
Location: Mayo Clinic Rochester — Rochester, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (31 Sites)
- Mayo Clinic Rochester — Rochester, Minnesota
- Memorial Sloan-Kettering Cancer Center — New York, New York
- The James Cancer Hospital and Solove Research Institute — Columbus, Ohio
- Uni of Texas - Md Anderson Cancer Center — Houston, Texas
- Huntsman Cancer Institute at The University of Utah — Salt Lake City, Utah
- Princess Alexandra Hospital Woolloongabba — Woolloongabba, Queensland
- Peter MacCallum Cancer Center — East Melbourne, Victoria
- Monash Medical Centre — Melbourne, Victoria
- Peking University People's Hospital — Beijing,
- Southern Medical University Nanfang Hospital — Guangzhou,
- The First Affiliated Hospital of Nanchang University — Nanchang,
- Tianjin Institute of Hematology & Blood Diseases Hospital — Tianjin,
- Chu de Clermont Ferrand — Clermont-Ferrand,
- IUCT Oncopole — Toulouse,
- Universitätsklinikum Augsburg — Augsburg,
- Uniklinik Koln — Cologne,
- Universitätsklinikum Ulm — Ulm,
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili — Brescia, Lombardy
- Osp. San Raffaele — Milan, Lombardy
- Asst Grande Ospedale Metropolitano Niguarda — Milan, Lombardy
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia — Sant'Andrea Delle Fratte (PG), Umbria
- Uniwersyteckie Centrum Kliniczne — Gda?sk,
- PRATIA MCM Kraków — Krakow,
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroc?aw,
- Seoul National University Hospital — Seoul,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.