Actively Recruiting
A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies
Led by Curis, Inc. · Updated on 2026-03-30
108
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.
CONDITIONS
Official Title
A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) according to WHO 2016 classification
- At least one measurable disease criterion per International Workshop on CLL
- For Cohort 1: partial response or partial response with lymphocytosis and positive measurable residual disease per specific criteria
- For Cohort 1: detectable measurable residual disease confirmed by ClonoSEQ assay
- For Cohort 1: actively taking zanubrutinib for at least 12 months
- For Cohort 1: acceptable organ function within 28 days prior to starting treatment
- For Cohort 2: relapsed disease ineligible for or exhausted standard care options
- For Cohort 2: actively taking zanubrutinib
- For Cohort 2: direct progression on zanubrutinib within 3 months prior to study entry with no other anticancer therapy since
- For Cohort 2: acceptable organ function within 28 days prior to starting treatment
- Creatine phosphokinase (CPK) less than 2.5 times the upper limit of normal
- Ability to tolerate contrast-enhanced CT scan
- Ability to swallow and retain oral medications
- Negative serum pregnancy test in women of childbearing potential
- Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception during and for 180 days after treatment
- Ability and willingness to provide informed consent
You will not qualify if you...
- Active second malignancy unless in remission with life expectancy over 2 years and approved by Sponsor
- Active malignancy other than CLL requiring systemic therapy (exceptions require discussion)
- Presence of high-risk CLL TP53 mutations and 17P deletion
- History of Grade 3 or higher rhabdomyolysis without complete recovery
- Prior chimeric antigen receptor-T cell therapy
- Prior investigational drugs within 28 days or 5 half-lives before treatment start
- Allogeneic hematopoietic stem cell transplant within 60 days before treatment start
- Clinically significant graft-versus-host disease requiring ongoing immunosuppressive medication adjustments
- Any systemic anticancer treatment other than zanubrutinib within 21 days or 5 half-lives before treatment start
- Use of certain medications within 7 days or 5 half-lives before treatment start, including those prolonging QT interval, peg-filgrastim, and St John's Wort
- History or ongoing drug-induced pneumonitis
- Stroke or intracranial hemorrhage within 6 months prior to treatment start
- Requirement for warfarin or similar anticoagulants within specified time before treatment; low molecular weight heparin allowed
- Vaccination with live-attenuated vaccine within 4 weeks prior to treatment
- History of hypersensitivity or anaphylaxis to study drugs or their ingredients
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Intolerance to contrast-enhanced CT due to allergy
- Major surgery within 28 days or minor surgery within 7 days prior to treatment
- Known HIV positive or AIDS-related illness unless undetectable or controlled after discussion
- Hepatitis B or C infection within 6 months prior to treatment unless controlled
- Active systemic infections or recent serious infections requiring hospitalization or intravenous antibiotics
- Concomitant illness preventing safe study participation
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mt Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
3
Texas Oncology - Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
A
Ahmed Hamdy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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