A Three-Arm Study of ME-401 Monotherapy in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL) of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell Non-Hodgkin s Lymphoma (NHL) and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Brief description of study

The purpose of this study is to look at how your body tolerates ME-401, how effective ME-401 may be, and how ME-401 is taken up by your body when administered orally as a single dose and after multiple doses over the course of the study, when ME-401 is taken alone, or in combination with either rituximab or zanubrutinib. ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. The study drug ME-401 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s19-00751
ClinicalTrials.gov Identifier: NCT02914938

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