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 (Sep 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 expression
histologically confirmed CD20 expression on lymphoma at relapse or progression of disease
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 in this trial
Prior BTK inhibitor (BTKi) refractory disease defined as disease progression or recurrence during or within 6 months of prior BTKi therapy
Cannot have received: pirtobrutinib (pirtobrutinib)
Prior exposure to pirtobrutinib
Cannot have received: CD3 T-cell engager
Exception: eligible if remission ≥ 24 months after last CD3 T-cell engager and histologically confirmed CD20 expression on lymphoma at relapse or progression
CD3 T-cell engager exposed disease
Cannot have received: solid organ transplantation
Prior solid organ transplantation
Lab requirements
Blood counts
Platelet count ≥ 75,000/mm^3 (≥ 50,000/mm^3 if disease-related cytopenia); Absolute neutrophil count ≥ 1000/mm^3 (≥ 750/mm^3 if disease-related cytopenia); Total hemoglobin ≥ 10 g/dL (≥ 7.5 g/dL if disease-related cytopenia)
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
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; Absolute neutrophil count ≥ 1000/mm^3; Total hemoglobin ≥ 10 g/dL; Activated partial thromboplastin time (or partial thromboplastin time) and prothrombin (or international normalized ratio) ≤ 1.5 ULN; Estimated creatinine clearance (CL) ≥ 30 mL/min
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 →Frequently asked questions
Is NCT06948786 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BTK inhibitor, pirtobrutinib, CD3 T-cell engager disqualifies patients from enrollment.
Does this trial require CD20?
Yes, CD20 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages