Actively Recruiting
A Phase 2 Study of Emavusertib with an Approved Bruton Tyrosine Kinase Inhibitor in Patients with Chronic Lymphocytic Leukemia and Other B-cell Malignancies
Led by Curis, Inc. · Updated on 2026-05-22
108
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anticancer activity of emavusertib combined with zanubrutinib in people with chronic lymphocytic leukemia (CLL) and other B-cell malignancies. This Phase 2 study focuses on two groups: Cohort 1 includes patients on zanubrutinib for at least 12 months with measurable residual disease, while Cohort 2 includes those with relapsed CLL who progressed on zanubrutinib after an initial response. The study aims to better understand treatment effects in these specific patient groups. Participants in both cohorts receive one of two doses of emavusertib taken twice daily alongside an approved dose of zanubrutinib as per label instructions. The study is divided into Part A, where initial dosing and safety are evaluated, and Part B, an expansion phase if Part A criteria are met. This design allows researchers to assess treatment responses and refine dosing strategies over time. During the study, participants will be monitored for up to approximately 23 months. Assessments include measuring undetectable measurable residual disease (uMRD) rates in Cohort 1 and overall response rates (ORR) in Cohort 2. Additional evaluations cover duration of response, progression-free survival, overall survival, and treatment-related side effects. Researchers will also track drug concentrations in the blood and perform regular scans and tests to monitor disease status and safety throughout the trial.
CONDITIONS
Brief 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...
- Male or female 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) per WHO 2016 classification
- Measurable disease according to International Workshop on CLL criteria
- For Cohort 1: partial response (PR) or partial response with lymphocytosis (PR-L), measurable residual disease positive (MRD+), detectable MRD by ClonoSEQ assay, and on zanubrutinib for at least 12 months
- For Cohort 2: relapsed disease ineligible for or exhausted standard therapies, currently taking zanubrutinib, progression on zanubrutinib within 3 months before study entry, no other anticancer therapy since
- Acceptable organ function within 28 days before starting treatment
- Creatine phosphokinase (CPK) less than 2.5 times upper limit of normal
- Ability to tolerate contrast-enhanced CT scan
- Ability to swallow and retain oral medications
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during the study and for 180 days after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Active second cancer unless in remission with life expectancy over 2 years and sponsor approval
- Active malignancy other than CLL requiring systemic therapy (exceptions may apply)
- High-risk CLL TP53 mutations or 17P deletion
- History of severe rhabdomyolysis without full recovery
- Prior chimeric antigen receptor-T cell therapy
- Prior investigational drugs within 28 days or 5 half-lives before treatment start
- Allogeneic stem cell transplant within 60 days before treatment start or ongoing significant graft-versus-host disease
- Systemic anticancer treatment within 21 days before treatment start except zanubrutinib
- Medications with high risk of prolonged QT interval or Torsades de Pointes within 7 days before treatment start
- Use of peg-filgrastim, St John's Wort within 7 days before treatment start
- History or ongoing drug-induced pneumonitis
- Stroke or intracranial hemorrhage within 6 months before treatment start
- Anticoagulation with warfarin or similar within 5 half-lives or 7 days before treatment start
- Vaccination with live-attenuated vaccine within 4 weeks before treatment start
- Known hypersensitivity to study drugs or their ingredients
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Allergy preventing contrast-enhanced CT scan
- Recent major surgery within 28 days or minor surgery within 7 days before treatment start
- Viral infections including HIV, hepatitis B or C, active infections requiring hospitalization or IV antibiotics within 28 days before treatment start
- Other illnesses that make study participation unsafe
- Pregnant or breastfeeding women
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 approximately 23 months
Participants receive oral emavusertib tablets twice daily and an approved dose of zanubrutinib capsules as per label to treat chronic lymphocytic leukemia or other B-cell malignancies.
Visits scheduled according to treatment cycles (each cycle = 28 days) with assessments up to Cycle 7 Day 1
Trial Site Locations
Total: 7 locations
1
Mt Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
2
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Texas Oncology - Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
5
Azienda Ospedaliero Universitaria Maggiore Della Carità
Novara, Italy, 28100
Actively Recruiting
6
Azienda Ospedale Università Padova
Padova, Italy, 35128
Actively Recruiting
7
Hospital Universitario Fundación Jiménez Díaz - START MADRID
Madrid, Spain, 28040
Actively Recruiting
Research Team
A
Ahmed Hamdy, MD
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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