This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.
Men and women aged ≥18 years.
Absolute neutrophil count (ANC) > 0.75 x 109/L. For subjects with documented bone marrow involvement ≥ 0.5 x 109/L
Platelet count > 50 x 109/L. For subjects with documented bone marrow involvement ≥ 30 x 109/L
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)
FOR PART 2 ONLY
Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for > 2 years without evidence of this and who have only CLL are considered eligible
Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.
Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose, major regional wall motion abnormalities upon baseline echocardiography), and cardiac arrhythmias requiring anti- arrhythmic therapy except for beta-blockers and digoxin.
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Treatment groupsSee each treatment group below.