ZE50-0134 for Lymphoma

Recruiting at 3 trial locations

Overseen By Ekaterina Dokukina, PhD MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eilean Therapeutics

Must be taking: BTKi

Must not be taking: Anti-arrhythmics

Disqualifiers: Richter's transformation, Cardiac disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ZE50-0134, a new potential drug for certain types of lymphoma, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), particularly when previous treatments have failed. The main goals are to assess the drug's safety, behavior in the body, and any early signs of effectiveness. Individuals with symptomatic CLL or SLL who have tried at least one or two therapies, such as BTKi or venetoclax, may be suitable for this trial. Participants must have a stable medical condition and not require ongoing immunosuppressive therapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require ongoing immunosuppressive therapy or certain heart medications, except for beta-blockers and digoxin. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ZE50-0134 is likely to be safe for humans?

Research shows that ZE50-0134 blocks certain proteins in cancer cells, helping to stop their growth. Studies have found that ZE50-0134 has little effect on normal immune cells, potentially causing fewer immunity issues compared to other treatments.

As a Phase 1 trial, the main goal is to determine the safety of ZE50-0134 at various doses. Although data is limited at this early stage, Phase 1 trials include strict safety checks, ensuring close monitoring of any concerning reactions. Participants might experience side effects, but these are usually mild and managed by the study team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lymphoma?

Unlike the standard treatments for lymphoma, which often include chemotherapy and immunotherapy, ZE50-0134 offers a novel approach by targeting a specific pathway involved in the growth of cancer cells. Researchers are excited about this treatment because it has the potential to be more precise, minimizing damage to healthy cells and potentially reducing side effects. Additionally, the flexibility in dosing levels allows researchers to fine-tune the treatment for optimal effectiveness while maintaining patient safety. This targeted strategy represents a promising advancement in the fight against lymphoma.

What evidence suggests that ZE50-0134 might be an effective treatment for lymphoma?

Research has shown that ZE50-0134 could be a promising treatment for certain types of lymphoma. It targets BCL2, a protein that helps cancer cells survive. This trial will evaluate different dose levels of ZE50-0134 to determine its effectiveness and safety. Early studies suggested that ZE50-0134 effectively fights cancer cells and causes fewer side effects, offering hope for patients with relapsed or hard-to-treat lymphomas. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with certain types of blood cancers that have come back or didn't respond to treatment. They must have a minimum level of white blood cells and platelets, normal liver function, and adequate kidney function. Participants need an ECOG performance status of 2 or less, meaning they can do most activities. Women who can get pregnant must test negative for pregnancy and use effective birth control; men also need to use contraception.

Inclusion Criteria

I have CLL or SLL, have symptoms, received at least one treatment including a BTK inhibitor, and have never been treated with venetoclax.

My white blood cell count is within the required range.

My total bilirubin levels are within normal limits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 utilizes a 3+3 design to determine the maximum tolerated dose of ZE50-0134

Up to 24 cycles, 4 weeks each

Dose Expansion

Part 2 involves dose expansion to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity

Up to 24 cycles, 4 weeks each

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ZE50-0134

Trial Overview The study tests ZE50-0134's safety and effectiveness in treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and select low-grade lymphomas that haven't responded well to previous treatments. It will look at how the body processes the drug, its impact on the disease, and any potential benefits.

How Is the Trial Designed?

Group I: ZE50-0134 Selected dose 2 Experimental Treatment 1 Intervention

The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study

Group II: ZE50-0134 Selected dose 1 Experimental Treatment 1 Intervention

The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study

Group III: ZE50-0134 Dose Level 5 Experimental Treatment 1 Intervention

Group IV: ZE50-0134 Dose Level 4 Experimental Treatment 1 Intervention

Group V: ZE50-0134 Dose Level 3 Experimental Treatment 1 Intervention

Group VI: ZE50-0134 Dose Level 2 Experimental Treatment 1 Intervention

Group VII: ZE50-0134 Dose Level 1 Experimental Treatment 1 Intervention

Group VIII: ZE50-0134 Dose Level -1 Experimental Treatment 1 Intervention

Optional and would only be performed Dose Level 1 is poorly tolerated

Who Is Running the Clinical Trial?

Eilean Therapeutics

Lead Sponsor

Trials

5

Recruited

370+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06708897

A Phase 1 Study of ZE50-0134 in Relapsed and Refractory ... This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory ...

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/4153/501307/A-Novel-Selective-BCL2-Inhibitor-with-Limited

A Novel Selective BCL2 Inhibitor with Limited Immune ... Together, this data suggests that ZE50-0134 is a highly effective BCL2 inhibitor with substantially less impact on the normal immune cells ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06708897?term=AREA%5BConditionSearch%5D(%22Chronic%20Lymphocytic%20Leukemia%22)&rank=6

A Phase 1 Study of ZE50-0134 in Relapsed and Refractory ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

4. synapse.patsnap.com synapse.patsnap.com/drug/da0638da52384a5a80415618d6a08b1d

Eiletoclax - Drug Targets, Indications, Patents Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas.

5. prnewswire.com prnewswire.com/news-releases/indolent-lymphoma-market-experiences-significant-growth-amid-evolving-therapeutic-landscape--delveinsight-302585978.html

Indolent Lymphoma Market Experiences Significant Growth ... ... ZE50-0134, and others. Discover the indolent lymphoma new treatment ... These treatments offer greater efficacy, reduced side effects, and more ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123107543

A Novel Selective BCL2 Inhibitor with Limited Immune ... ZE50-0134 is a highly effective BCL2 inhibitor with substantially less impact on the normal immune cells responsible for both anti-tumor and anti-infectious ...

7. withpower.com withpower.com/trial/phase-1-lymphoma-2025-4cc9b

ZE50-0134 for Lymphoma This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory ...

8. delta.larvol.com delta.larvol.com/Products/?ProductId=694546e9-5a7a-4411-a4b3-98d44a181576

eiletoclax (ZE50-0134) / Eilean Therap Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Administration of ZE50-0134 at 5 Dose Levels ...