Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06948786
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Recurrent Follicular Lymphoma
  • Refractory Follicular Lymphoma

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Given PO
  • Mosunetuzumab — BIOLOGICAL
    Given SC or IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample and oral swab and/or rectal swab collection
  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial tests how well pirtobrutinib and mosunetuzumab work in treating patients with grade 1-3a follicular lymphoma (FL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pirtobrutinib, a type of tyrosine kinase inhibitor, works by blocking the action of the Bruton tyrosine kinase (BTK) protein. The BTK protein signals cancer cells to multiply, and blocking it may help keep cancer cells from growing. It could also improve T cell fitness and decrease inflammation, therefore, may improve the efficacy and safety of T cell-based therapies, such as mosunetuzumab. Mosunetuzumab is a bispecific antibody that binds both T cells and the lymphoma cancer cells and harnesses T cells to interfere with the ability of cancer cells to grow and spread. Giving pirtobrutinib and mosunetuzumab together may kill more tumor cells in patients with relapsed or refractory grade 1-3a FL and potentially decreases some side effects of mosunetuzumab which are related to T cells being activated (e.g., cytokine release syndrome).

Key Dates

Start date
Nov 17, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

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

Arms

  • Experimental: Treatment (pirtobrutinib, mosunetuzumab)
    Patients receive pirtobrutinib PO QD on 7 days prior to the start of mosunetuzumab (day -7) and continue it until up to 52 weeks. Patients receive mosunetuzumab subcutaneously (SC) or intravenously (IV) on days 1, 8, and 15 of cycle 1 then on day 1 of remaining cycles. Cycles of mosunetuzumab repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients with a CR after cycle 8 discontinue mosunetuzumab. Patients also undergo blood sample and oral swab and/or rectal swab collection, tissue biopsy, CT, and PET/CT throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy at screening and after cycle 8.

Primary Outcome Measure

Complete remission (CR) rate [ Time Frame: After cycle 8 of mosunetuzumab (cycle length = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Mengyang Di, MD, PhD
[email protected]
206-606-2519
Mengyang Di, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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