NCT06948786

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

OUTLINE: Patients receive pirtobrutinib orally (PO) once daily (QD) on 7 days prior to the start of mosunetuzumab (day -7) and continue it until up to 52 weeks. Patients receive mosunetuzumab 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 (optional), computed tomography (CT), and positron emission tomography (PET)/CT throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy at screening and after cycle 8. After completion of study treatment, patients are followed up at 30 days then at standard of care intervals for up to 4 years.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-11-17
• Primary completion: 2031-07-31
• Completion: 2031-07-31
• First posted: 2025-04-29
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study