Full TitleA Two-Arm, 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) and an Open-Label Study of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell Non-Hodgkin’s Lymphoma.
ME-401 is an investigational drug that works by inhibiting PI3K delta, a protein that plays a critical role in the growth of certain blood cancer cells. In this study, researchers are seeking the best dose of ME-401 to give to patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) or follicular lymphoma that has come back or continued growing despite prior therapy. ME-401 is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CLL/SLL or follicular lymphoma that has come back or continued growing despite prior therapy.
- Patients may not have previously received treatments that target PI3K delta or BTK, or they must have been unable to tolerate BTK inhibitors.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.