OncoMatch/Clinical Trials/NCT05091424
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
Is NCT05091424 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Mosunetuzumab and Tocilizumab for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Treatment: Mosunetuzumab · Tocilizumab · Venetoclax · Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor
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 up to three cycles of mosunetuzumab administration
Cannot have received: CD20/CD3-directed bispecific antibody (mosunetuzumab)
treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies
Cannot have received: allogenic stem cell transplant
allogenic stem cell transplant
Lab requirements
Blood counts
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
Liver function
adequate liver function unless directly attributable to the participant's cll
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05091424 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD20/CD3-directed bispecific antibody, allogenic stem cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages