RecruitingPhase 2NCT06948786

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

PROMOTE-FL: Pirtobrutinib and Mosunetuzumab to Enhance Treatment Efficacy for Patients With Relapsed/Refractory Follicular Lymphoma


Sponsor

University of Washington

Enrollment

22 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pirtobrutinib and mosunetuzumab — for people with follicular lymphoma (a slow-growing type of blood cancer) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with follicular lymphoma (grades 1 through 3A) confirmed by biopsy - Your lymphoma has relapsed or failed to respond after at least two prior treatments, including a therapy targeting CD20 - You are otherwise in good health and able to perform daily activities - You have at least one measurable area of disease on imaging **You may NOT be eligible if...** - Your previous treatment side effects have not sufficiently resolved - You have certain active infections, significant heart problems, or other serious medical conditions - You have prior treatment with certain specific drugs used in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Given PO

BIOLOGICALMosunetuzumab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample and oral swab and/or rectal swab collection

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREComputed Tomography

Undergo CT and PET/CT

PROCEDUREPositron Emission Tomography

Undergo PET/CT

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06948786


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