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
University of Washington
22 participants
Nov 17, 2025
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
Plain Language Summary
Simplified for easier understanding
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Interventions
Given PO
Given IV
Undergo blood sample and oral swab and/or rectal swab collection
Undergo tissue biopsy
Undergo CT and PET/CT
Undergo PET/CT
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Ancillary studies
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06948786