SHS_492346 PAGJ CMEI 16154
A Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)
The purpose of this study is to determine the minimum biologically effective dose of ME-401; determine the maximally tolerated dose of ME-401 and determine the dose limiting toxicities (DLTs) of ME-401. Secondary objectives to evaluate the safety profile and efficacy of ME-401. This is a Phase 1b, open-label, dose escalation/expansion study with seven planned dose levels (Cohorts) of ME-401. DLT will be assessed within the first 56 days (8 weeks). A Continual Reassessment Method (CRM) model will be used to determine dose escalation/de-escalation. Dose levels will consist of 6 subjects and can be expanded to enroll up to 12 subjects. The total number of cohorts depends on the incidence of DLTs.
•Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL
•No prior therapy with PI3Kd inhibitors
•No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy
•QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
•For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0
•Known histological transformation from CLL to an aggressive lymphoma
•Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
•Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody
•Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody
•Ongoing drug-induced pneumonitis
•History of clinically significant cardiovascular abnormalities
John Pagel, M.D.
MEI Pharma, Inc.