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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 · View on ClinicalTrials.gov ↗
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). 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 two 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 Studied
Interventions
- DRUG Venetoclax
- DRUG Mosunetuzumab
- DRUG Tocilizumab
Study Locations (20)
Other
- 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
Lombardy
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili — Brescia
- Osp. San Raffaele — Milan
- Asst Grande Ospedale Metropolitano Niguarda — Milan
Victoria
- Peter MacCallum Cancer Center — East Melbourne
- Monash Medical Centre — Melbourne
Minnesota
- Mayo Clinic Rochester — Rochester
New York
- Memorial Sloan-Kettering Cancer Center — New York
Ohio
- The James Cancer Hospital and Solove Research Institute — Columbus
Texas
- Uni of Texas - Md Anderson Cancer Center — Houston
Utah
- Huntsman Cancer Institute at The University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2030-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05091424
The ClinicalTrials.gov registry entry for NCT05091424 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05091424 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Lombardy, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05091424 about?
NCT05091424 is a clinical study titled "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". 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). This study will also allow participants who are currently progressing on a Bruton t...
What is the current status of trial NCT05091424?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2022-03-07. Estimated completion is 2030-02-28.
What conditions does trial NCT05091424 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05091424?
The interventions under investigation include: Venetoclax (DRUG), Mosunetuzumab (DRUG), Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05091424?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05091424 being conducted?
This trial has 20 study locations across Minnesota, New York, Ohio, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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