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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2026-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Interventions

DRUG

Mosunetuzumab

Participants will receive subcutaneous (SC) mosunetuzumab.

DRUG

Tocilizumab

Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.

DRUG

Venetoclax

Participants will receive daily oral venetoclax.

DRUG

Rituximab

Participants will receive IV rituximab as per protocol.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2031-02-10
Completion
2032-02-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • France
  • Germany
  • Italy
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091424 on ClinicalTrials.gov