Phase 2 Study of Pirtobrutinib and Glofitamab Combination Therapy for Patients With Relapsed Mantle Cell Lymphoma After BTK Inhibitor Treatment

What this Trial Is About

This trial studies patients with relapsed or refractory Mantle Cell Lymphoma MCL who have previously been treated with BTK inhibitors. Researchers are evaluating the safety and response of combining two drugs Pirtobrutinib and Glofitamab. The main goals are to see if the combination produces additive or synergistic effects and achieves high rates of complete remission with no residual disease. Participants take Pirtobrutinib as an oral tablet throughout the study. Treatment occurs in three phases an initial ramp-up phase with intravenous Obinutuzumab and step-up dosing of Glofitamab a fixed course combination phase with repeated Glofitamab infusions over cycles 3 to 12 and finally, a maintenance phase where Glofitamab is stopped and only daily oral Pirtobrutinib is continued. During the study, participants undergo evaluations after six cycles approximately 18 weeks and after twelve cycles of treatment. Researchers assess efficacy using response criteria and measure minimal residual disease. Safety is monitored by tracking adverse events and laboratory tests. Patients will be followed for up to five years to evaluate progression-free survival and duration of response.

A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.