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Phase 1 Study of ZE50-0134 for Relapsed and Refractory Leukemias and Lymphomas

This study is testing a new oral capsule, ZE50-0134, for people with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and certain other low-grade lymphomas that have come back or not responded to previous treatments. The main goals are to see how safe ZE50-0134 is and what side effects it might cause. Researchers will also look at how the drug moves through the body and if it shows any early signs of working against the cancer. You might be able to join if you are at least 18 years old and have CLL/SLL without specific genetic changes (del(17p)/TP53) and have had at least two prior treatments, including a BTK inhibitor and venetoclax (or couldn't take them).

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves two parts: a dose escalation phase to find the right dose, and a dose expansion phase to further evaluate safety and early effectiveness. The study plans to enroll 66 participants.
What's involved
You would take ZE50-0134 as oral capsules once a day. The study will measure side effects for up to 24 cycles, with each cycle lasting 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be measured for up to 24 cycles, with each cycle lasting 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06708897

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Lomond Therapeutics Holdings, Inc.
~84 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Lonitoclax (ZE50-0134)

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment-emergent adverse events and serious adverse events
Measured over From first dose through 30 days after the last dose; treatment may continue for up to 24 cycles (28 days per cycle).
+2 more outcomes measured

Conditions

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

Explore related trials

Chronic Lymphocytic LeukemiaHematologic NeoplasmLymphoplasmacytic LymphomaMarginal Zone LymphomaSmall Lymphocytic LymphomaWaldenstrom Macroglobulinemia

Where it's being run

5 sites across 4 states
Ohio2
Kentucky1
North Carolina1
Texas1

Who to contact

Ekaterina Dokukina, PhD MD
[email protected]
+1 858 353 4108
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Part 1: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 2 prior therapies that included a covalent Bruton tyrosine kinase inhibitor (BTKi) and venetoclax, or after the participant declined venetoclax; or 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.
Part 2: Relapsed or refractory CLL or SLL, as defined by iwCLL, after at least 1 prior therapy that included a BTKi; participants must be venetoclax naive. 3. Disease requiring therapy in the investigator's opinion. 4. Adequate bone marrow, liver, and renal function during screening:
Absolute neutrophil count greater than 0.75 x 10\^9/L; for participants with documented bone marrow involvement, at least 0.5 x 10\^9/L.
Platelet count greater than 50 x 10\^9/L; for participants with documented bone marrow involvement, at least 30 x 10\^9/L.
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. Participants with suspected or known Gilbert disease may have total bilirubin up to 3 times the upper limit of normal if predominantly unconjugated.
Creatinine- or cystatin C-based glomerular filtration rate at least 60 mL/min, or at least 40 mL/min with a normal urine neutrophil gelatinase-associated lipocalin level. Estimated GFR is calculated using the Modification of Diet in Renal Disease formula. 5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2. 6. For women of childbearing potential, a negative serum or urine pregnancy test within 7 days before the first dose and a negative result before each treatment cycle. Pregnancy testing is not required for women older than 50 years with at least 12 months of amenorrhea; women aged 50 years or younger with at least 6 months of spontaneous amenorrhea and follicle-stimulating hormone greater than 40 mIU/mL; or permanently sterilized women, including hysterectomy, bilateral salpingectomy, or uterine ablation. 7. Women and men of reproductive potential must agree to use highly effective contraception from signing informed consent until 90 days after the last dose of study drug. 8. Ability to understand and willingness to sign written informed consent, including consent for genetic biomarker analyses from tissue and plasma, before study-specific procedures.

What this trial measures

  • Incidence and severity of treatment-emergent adverse events and serious adverse eventsFrom first dose through 30 days after the last dose; treatment may continue for up to 24 cycles (28 days per cycle).

    Number and percentage of participants with treatment-emergent adverse events, serious adverse events, clinically significant laboratory abnormalities, adverse events related to lonitoclax, and adverse events leading to treatment discontinuation. Adverse events are graded using NCI CTCAE Version 5.0.

  • Incidence of dose-limiting toxicities in Part 1Cycle 1 (Days 1-28).

    Number and percentage of Part 1 participants experiencing a protocol-defined dose-limiting toxicity during the dose-limiting toxicity assessment period.

  • Determination of the biologically effective dose and/or maximum tolerated doseAfter completion of Cycle 1 for evaluable participants in each Part 1 dose cohort.

    The selected dose is determined from the totality of safety, dose-limiting toxicity, pharmacokinetic, pharmacodynamic, and early response data across Part 1 dose cohorts according to the protocol-defined dose-escalation rules.