Actively Recruiting
A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas
Led by Lomond Therapeutics Holdings, Inc. · Updated on 2025-12-05
66
Participants Needed
4
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.
CONDITIONS
Official 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
- For Part 1: Symptomatic CLL or SLL without del(17p)/TP53 who have received at least 2 prior therapies including a BTKi and venetoclax (or declined venetoclax)
- For Part 1: Progressive low-grade lymphoma (including marginal zone lymphoma, lymphoplasmacytic lymphoma, Waldenstrom's macroglobulinemia) with at least 2 prior therapies including a BTKi and CD20 antibody therapy
- For Part 2: Symptomatic CLL or SLL who have received at least 1 prior therapy including a BTKi and are venetoclax naive
- Adequate bone marrow, liver, and kidney function as defined by specific lab values 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 the study and 90 days after last dose
- Ability and willingness to sign informed consent including consent for genetic biomarker testing
You will not qualify if you...
- For Part 2: Prior treatment with venetoclax
- Known active Richter's transformation (patients in remission for over 2 years without evidence of Richter's transformation and only CLL are eligible)
- Known hypersensitivity to study drug or related agents
- Significant cardiac disease including congestive heart failure NYHA Class greater than II, uncontrolled coronary artery disease, recent angina or myocardial infarction, or arrhythmias requiring anti-arrhythmic therapy except beta-blockers and digoxin
- Active infections including cytomegalovirus, hepatitis B or C, or active SARS-CoV-2; prior COVID-19 infection allowed if fully recovered over 14 days
- Serious infections grade greater than 2 requiring parenteral therapy
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days
- Allogeneic bone marrow transplant within 4 months before first dose
- Active cancer limiting survival to less than 2 years or requiring concurrent active therapy (some exceptions apply)
- Physical exam or lab findings contraindicating investigational therapy or high risk for treatment
- Unresolved treatment toxicities grade 2 or higher (excluding alopecia)
- Ongoing immunosuppressive therapy including systemic corticosteroids for cancer or other conditions (topical or low-dose steroids allowed)
- Major surgery or significant trauma within 4 weeks before first dose
- Breastfeeding women who do not discontinue breastfeeding before and during treatment and for 3 months after
- QTcF interval greater than 470 msec not correctable with treatment
AI-Screening
AI-Powered Screening
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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
CONTACT
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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