Hoffmann-La Roche
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, compared to standard-of-care rituximab plus venetoclax.
Inclusion Criteria: * 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: agreem…
Participants will receive subcutaneous (SC) mosunetuzumab.
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Participants will receive daily oral venetoclax.
Participants will receive IV rituximab as per protocol.