OncoMatch/Clinical Trials/NCT06708897
A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies
Is NCT06708897 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Lonitoclax (ZE50-0134) for cll / sll.
Treatment: Lonitoclax (ZE50-0134) — This Phase 1, open-label, multicenter study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of lonitoclax (ZE50-0134) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade B-cell lymphomas. The study has two sequential parts. Part 1 uses dose escalation to determine the biologically effective dose and/or maximum tolerated dose of lonitoclax. Participants receive a 3-day step-up regimen followed by continuous once-daily or twice-daily oral dosing in 28-day cycles. Part 2 is a randomized dose-expansion comparison of two selected lonitoclax dose levels in venetoclax-naive participants with relapsed or refractory CLL/SLL. Treatment may continue for up to 12 cycles and, for participants deriving clinical benefit, for up to 24 cycles with approval from the Medical Monitor.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Bruton tyrosine kinase inhibitor — CLL or SLL (Part 1: at least 2 prior therapies including BTKi and venetoclax or declined venetoclax; Part 2: at least 1 prior therapy including BTKi, venetoclax naive)
after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; ... after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive
Must have received: venetoclax (venetoclax) — CLL or SLL (Part 1: at least 2 prior therapies including BTKi and venetoclax or declined venetoclax; Part 2: venetoclax naive)
after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; ... after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive
Must have received: Bruton tyrosine kinase inhibitor or CD20 antibody-based therapy — progressive low-grade lymphoma (marginal zone lymphoma or lymphoplasmacytic lymphoma)
progressive low-grade lymphoma, including marginal zone lymphoma or lymphoplasmacytic lymphoma (including Waldenstrom macroglobulinemia), after at least 1 prior therapy that included either a BTKi or CD20 antibody-based therapy
Cannot have received: venetoclax (venetoclax)
Exception: Part 2 only
Part 2 only: Prior venetoclax treatment
Lab requirements
Blood counts
Absolute neutrophil count >0.75 x 10^9/L (or >0.5 x 10^9/L with bone marrow involvement); platelet count >50 x 10^9/L (or >30 x 10^9/L with bone marrow involvement)
Kidney function
Creatinine- or cystatin C-based GFR at least 60 mL/min, or at least 40 mL/min with a normal urine neutrophil gelatinase-associated lipocalin level
Liver function
AST and ALT no greater than 3.0 times the upper limit of normal; total bilirubin no greater than 1.5 times the upper limit of normal (up to 3x ULN if Gilbert disease and unconjugated);
Adequate bone marrow, liver, and renal function during screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Norton Cancer Institute, St. Matthews Campus · Louisville, Kentucky
- University of North Carolina at Chapel Hill · Chapel Hill, North Carolina
- University of Cincinnati · Cincinnati, Ohio
- The Ohio State University · Columbus, Ohio
- UT Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06708897 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior venetoclax disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify