OncoMatch/Clinical Trials/NCT06948786
Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
Is NCT06948786 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mosunetuzumab and Pirtobrutinib for grade 1 follicular lymphoma.
Treatment: Pirtobrutinib · Mosunetuzumab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 expression
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20-directed therapy
had received prior treatment with an anti-CD20-directed therapy
Cannot have received: BTK inhibitor
Exception: Patients with prior BTKi exposure but not meeting the criteria of BTKi refractoriness can be enrolled
Prior BTK inhibitor (BTKi) refractory disease defined as disease progression or recurrence during or within 6 months of prior BTKi therapy
Cannot have received: BTK inhibitor (pirtobrutinib)
Prior exposure to pirtobrutinib
Cannot have received: CD3 T-cell engager
Exception: eligible if remission ≥ 24 months after last treatment and CD20 expression confirmed at relapse/progression
CD3 T-cell engager exposed disease. However, these patients may be eligible if they stay in remission for at least 24 months after the last treatment with CD3 T-cell engager and have histologically confirmed CD20 expression on lymphoma at relapse or progression of disease
Cannot have received: monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate
Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate within 4 weeks before first pirtobrutinib administration
Cannot have received: systemic immunotherapeutic agents (T-cell mechanism) (cytokine therapy, anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with systemic immunotherapeutic agents for which the mechanism of action involves T cells, including but not limited to cytokine therapy and anti-CTLA-4, anti-programmed death (PD)-1 and anti-PD-ligand 1 therapeutic antibodies, within 12 weeks or 5 half-lives of the drug, whichever was shorter, before first pirtobrutinib administration
Cannot have received: chemotherapeutic agent or other anti-cancer agent
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever was shorter, prior to first pirtobrutinib administration
Cannot have received: radiotherapy
Exception: If patients received radiotherapy within 4 weeks prior to the first pirtobrutinib administration, patients must have had at least one measurable lesion outside of the radiation field. Patients who had only one measurable lesion that was previously irradiated but subsequently progressed are eligible
Treatment with radiotherapy within 2 weeks prior to the first pirtobrutinib administration
Cannot have received: stem cell transplant (allogeneic, autologous)
Exception: allowed if >60 days since SCT and no active GVHD, cytopenia, need for anti-cytokine therapy, residual neurotoxicity > grade 1, or ongoing immunosuppressive therapy
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing: Active GVHD; cytopenia from incomplete blood cell count recovery post-transplant; need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > grade 1 from CAR-T therapy; ongoing immunosuppressive therapy (> 20 mg prednisone or equivalent daily) or have been off immunosuppressive agents < 2 months
Cannot have received: CAR-T cell therapy
Exception: allowed if >60 days since CAR-T and no active GVHD, cytopenia, need for anti-cytokine therapy, residual neurotoxicity > grade 1, or ongoing immunosuppressive therapy
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing: Active GVHD; cytopenia from incomplete blood cell count recovery post-transplant; need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > grade 1 from CAR-T therapy; ongoing immunosuppressive therapy (> 20 mg prednisone or equivalent daily) or have been off immunosuppressive agents < 2 months
Cannot have received: solid organ transplantation
Prior solid organ transplantation
Lab requirements
Blood counts
Platelet count ≥ 75,000/mm^3 without transfusion within 14 days prior to first dose; absolute neutrophil count ≥ 1000/mm^3 in absence of growth factor support; hemoglobin ≥ 10 g/dL without transfusion within 21 days prior to first dose; exceptions for extensive marrow involvement, splenic sequestration, or disease-related cytopenia: platelet count ≥ 50,000/mm^3, absolute neutrophil count ≥ 750/mm^3, hemoglobin ≥ 7.5 g/dL after PI confirmation
Kidney function
Estimated creatinine clearance (CL) ≥ 30 mL/min by Cockcroft-Gault formula or other institutional standard methods
Liver function
Aspartate aminotransferase and alanine aminotransferase ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in patients with documented liver involvement or Gilbert syndrome
Cardiac function
Documented LVEF ≤ 40% in the 12 months prior to enrollment [excluded]; ≥ grade 3 NYHA functional classification system of heart failure [excluded]; unstable angina or acute coronary syndrome within past 2 months [excluded]; history of myocardial infarction within 3 months [excluded]; uncontrolled or symptomatic arrhythmias [excluded]
Aspartate aminotransferase and alanine aminotransferase ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in patients with documented liver involvement or Gilbert syndrome; Platelet count ≥ 75,000/mm^3 without transfusion within 14 days prior to first dose; absolute neutrophil count ≥ 1000/mm^3 in absence of growth factor support; hemoglobin ≥ 10 g/dL without transfusion within 21 days prior to first dose; exceptions for extensive marrow involvement, splenic sequestration, or disease-related cytopenia: platelet count ≥ 50,000/mm^3, absolute neutrophil count ≥ 750/mm^3, hemoglobin ≥ 7.5 g/dL after PI confirmation; Documented LVEF ≤ 40% in the 12 months prior to enrollment [excluded]; ≥ grade 3 NYHA functional classification system of heart failure [excluded]; unstable angina or acute coronary syndrome within past 2 months [excluded]; history of myocardial infarction within 3 months [excluded]; uncontrolled or symptomatic arrhythmias [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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