Actively Recruiting
Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas
Led by Lomond Therapeutics Holdings, Inc. · Updated on 2025-12-05
66
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ZE50-0134 to assess its safety, how the body processes it, its biological effects, and early signs of effectiveness in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and certain low-grade lymphomas. This Phase 1, open-label trial includes patients who have already received prior treatments and focuses on determining the appropriate dosing and safety of this new oral medication. The study is divided into two parts. Part 1 uses a dose escalation design where patients receive increasing doses of ZE50-0134 in oral capsules once daily to find the maximum tolerated dose. Part 2 expands the study by treating patients with selected doses based on Part 1 findings, focusing on patients who have not previously received venetoclax but have been treated with other therapies. Dose adjustments and safety monitoring guide the dosing decisions. Participants will be monitored through up to 24 treatment cycles, each lasting 4 weeks, to evaluate side effects and treatment responses. Researchers will collect blood samples to study drug levels and measure outcomes such as overall response rate, duration of response, progression-free survival, and time to next treatment. Safety assessments include tracking adverse events, and women of childbearing potential will undergo pregnancy testing during the study. The total participation duration depends on treatment cycles and individual response.
CONDITIONS
Brief Title
A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Patients with symptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma as defined by iwCLL criteria
- For Part 1: Patients must have received at least 2 prior therapies including a BTK inhibitor and venetoclax or declined venetoclax
- For Part 1: Patients with progressive low-grade lymphoma must have received at least 2 therapies including a BTK inhibitor and CD20 antibody therapy
- For Part 2: Patients must have received at least 1 prior therapy including a BTK inhibitor and be venetoclax naive
- Adequate bone marrow, liver, and kidney function based on specified lab tests within 7 days before first dose
- ECOG performance status of 2 or less
- Negative pregnancy test within 7 days before first dose for women of childbearing potential
- Women and men of reproductive potential must agree to use highly effective contraception during and for 90 days after treatment
- Ability and willingness to provide written informed consent including consent for genetic biomarker analysis
You will not qualify if you...
- For Part 2: No prior venetoclax treatment
- Known active Richter's transformation unless treated and in remission for more than 2 years with only CLL
- Known allergy to the study drug or related agents
- Significant heart disease including congestive heart failure greater than NYHA Class II, recent unstable angina, or recent myocardial infarction
- Active infections including cytomegalovirus, hepatitis B or C, or SARS-CoV-2 infection
- Serious infections of Grade greater than 2 requiring intravenous therapy
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days before enrollment
- Allogeneic bone marrow transplant within 4 months before first dose
- Active cancers limiting survival to less than 2 years or requiring active therapy other than certain localized or treated cancers
- Physical exam or lab findings placing subject at high risk for treatment
- Unresolved toxicity from previous treatments of Grade 2 or higher except alopecia
- Ongoing immunosuppressive therapy except low-dose steroids or topical/inhaled corticosteroids
- Major surgery or significant trauma within 4 weeks before first dose
- Breastfeeding women must stop breastfeeding before and during treatment and for at least 3 months after treatment
- QTcF interval greater than 470 msec that cannot be corrected with treatment or medication adjustments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles, each cycle lasting 4 weeks
Participants receive oral capsules of ZE50-0134 once daily as part of dose escalation or dose expansion to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 4 locations
1
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
Actively Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
3
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
E
Ekaterina Dokukina, PhD MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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