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.
Sequential
ZE 50-0134
Drugoral capsules QD
8
Treatment groupsSee each treatment group below.
Incidence of AEs and SAEs
Frequency, severity, and relationship to study drug of any TEAEs or abnormalities of laboratory tests; SAEs; and AEs leading to discontinuation of study treatment
Overall Response Rate (ORR)
The ORR is defined as the proportion of subjects who have a best overall response of PR or better as determined by investigators using the iwCLL guidelines, Lugano guidelines, or Waldenstrom guidelines.
Assess duration of response (DOR)
DOR is defined in responders as the time from documentation of tumor response (date of first PR or better response) to the date of disease progression as determined by the investigator using iwCLL guidelines, Lugano guidelines, Waldenstrom guidelines or death due to any cause.
Progression-free survival (PFS)
PFS is defined as time from first dose until progression as assessed by the investigator using iwCLL guidelines, Lugano guidelines or death due to any cause.
Time to next treatment (TTNT)
TTNT is defined as time from first dose to the initiation of alternative treatment other than ZE50-0134 for CLL or death.
Caspase 3 activation level
Measuring caspase 3 activation in CLL and lymphoma cells
Immune cells count
Serial immune CD8 T-cells, NK cells, and normal B-cells during ZE50-0134 therapy
Rate of undetectable Measurable residual disease (uMRD) response in bone marrow and blood
Rate of uMRD is defined as the proportion of evaluable subjects with MRD undetectable in bone marrow and blood
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