Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituxim… (NCT07583810) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
United States35 participantsStarted 2026-12-16
Plain-language summary
This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib in combination with rituximab may be safe, tolerable and/or effective in treating patients with marginal zone lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* Age: ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Diagnosis of MZL including splenic marginal zone lymphoma (SMZL), extra nodal marginal zone lymphoma (ENMZL) and nodal marginal zone lymphoma (NMZL), established by histologic assessment
* Requiring treatment for MZL. Patients receiving prior systemic therapy as well as treatment naïve patients are eligible
* Local radiotherapy not exceeding a total dose of 20 Gy at least 2 weeks prior the first dose of study therapy is allowed
* Radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy (as defined by Lugano Classification for non-Hodgkin lymphoma \[NHL\])
* Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed
* Subjects with skin extranodal marginal zone lymphoma (EMZL) who do not meet the radiographically measurable disease criteria described herein are eligible provided that skin lesion measures ≥ 1.5 cm in diameter and is documented by photo or there are multiple skin lesions measuring \> 1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL
* Subjec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a combination of nemtabrutinib, a non-covalent BTK inhibitor, and rituximab — how does this differ from BTK inhibitors I may have already tried or been offered, and does my treatment history affect whether this combination might be relevant for my situation?
2The trial starts with a safety lead-in phase focused on identifying unacceptable toxicity before moving into the broader Phase 2 — what does that mean for someone who joins early in terms of the unknowns around side effects compared to treatments that are already fully approved?
3Since this trial is listed as 'not yet recruiting,' do you know when it's expected to open, and is it worth waiting for it versus starting a standard treatment now given the pace of my diagnosis?
4My specific subtype of marginal zone lymphoma — whether it's gastric MALT, splenic, nodal, or another form — matters a lot in treatment decisions; do you think my particular subtype would be a meaningful factor in whether this trial is even worth exploring with my care team?
5The main goal of the Phase 2 portion is measuring complete response rate — what does achieving a complete response typically mean in marginal zone lymphoma, and how does that compare to what standard-of-care options might realistically offer me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of unacceptable toxicity (Safety lead-in)
Timeframe: During cycle 1 (cycle length = 28 days)