Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07583810
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma
  • Extranodal Marginal Zone Lymphoma
  • Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
  • Lymphoma
  • Marginal Zone Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nemtabrutinib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Dec 16, 2026
Status verified
May 2026
Primary completion
May 2, 2028
Completion
May 2, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nemtabrutinib, rituximab)
    Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on days 1, 8, 15, and 22 of cycles 1 and 3 and on day 1 of cycles 5-12. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with a CR or PR may optionally continue to receive nemtabrutinib PO QD for up to an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT, CT, or MRI throughout the study. Additionally, patients may optionally undergo bone marrow biopsy and tissue biopsy on study.

Primary Outcome Measure

Incidence of unacceptable toxicity (Safety lead-in) [ Time Frame: During cycle 1 (cycle length = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Geoffrey Shouse
[email protected]
626-218-2405
Geoffrey Shouse (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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