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 of ME-401. Secondary objectives to evaluate the safety profile and efficacy of ME-401.
Cancer (Oncology), Cancer (Oncology) - Lymphoma
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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