RecruitingPhase 1NCT06708897

A Study of Lonitoclax (ZE50-0134) in Relapsed or Refractory B-cell Malignancies

Phase 1 Study of Lonitoclax (ZE50-0134) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas

Sponsor

Lomond Therapeutics Holdings, Inc.

Enrollment

84 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

CLL/SLL CLL (Chronic Lymphocytic Leukemia)Marginal Zone Lymphoma (MZL)SLL (Small Lymphocytic Lymphoma)Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new drug called ZE50-0134 in people with relapsed or treatment-resistant chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or related low-grade lymphomas that have come back after multiple prior treatments. **You may be eligible if...** - You are 18 or older - You have CLL, SLL, or a related low-grade lymphoma (marginal zone lymphoma, Waldenstrom's macroglobulinemia, etc.) that has returned or stopped responding to treatment - You have already tried standard therapies including a BTK inhibitor (like ibrutinib or acalabrutinib) and venetoclax (or chose not to take it) - Your cancer is still causing symptoms **You may NOT be eligible if...** - You have not yet tried a BTK inhibitor - You have conditions that would make participation unsafe - Your cancer type is not covered under the study eligibility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLonitoclax (ZE50-0134)

Lonitoclax is supplied as immediate-release white opaque soft gelatin capsules in 25 mg, 100 mg, and 250 mg strengths. Participants receive a 3-day step-up regimen followed by the assigned oral dose once daily (QD) or twice daily (BID) in a fed state, administered within 1 hour of food. Each cycle is 28 days. Treatment continues for up to 12 cycles and may continue for up to 24 cycles in participants deriving clinical benefit, at the investigator's discretion with Medical Monitor approval. Participants receive inpatient monitoring and tumor lysis syndrome prophylaxis during the initial step-up period.

Locations(5)

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06708897

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