Not Yet RecruitingPhase 2

Nemtabrutinib, Bortezomib, and Rituximab for WM

South Korea19 participantsStarted 2026-06-01

Plain-language summary

This is a phase II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of nemtabrutinib in combination with bortezomib and rituximab

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Confirmed diagnosis of WM in accordance with the consensus panel of the IWWM (per local evaluation), and treatment naïve
✓. Symptomatic disease meeting at least 1 of the recommendations from the IWWM for requiring treatment.
✓. Measurable disease defined as serum monoclonal IgM \> 0.5g/dL.
✓. Is an individual of any sex/gender, who are at least 19 years of age on the day of signing informed consent (ICF).
✓. Participants Assigned Male Sex at Birth
✓. The participant (or legally acceptable representative if applicable) has provided documented informed consent/assent for the trial.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
✓. The ability to swallow and retain oral medication.

Exclusion criteria

✕. Active HBV/HCV infection.
✕. Positive for human immunodeficiency virus (HIV).
✕. Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).
✕. Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course.
✕. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
✕. QTc prolongation (defined as a QTcF \>450 msecs) or other significant ECG abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
✕. A history of anaphylaxis or hypersensitivity to investigational products or components of investigational products (nemtabrutinib, bortezomib, rituximab).
✕. History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.

What they're measuring

Major response rate (MRR)

Timeframe: At the end of Cycle 6 (each cycle is 28 days)

Trial details

NCT IDNCT07464210

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-08-01

Contact for this trial

Ja Min Byun, MD, PhD

82-02-2072-7215 jaminbyun@snu.ac.kr

View on ClinicalTrials.gov More Waldenstrom Macroglobulinemia trials