What is emavusertib studying for chronic lymphocytic leukemia?

Emavusertib is being studied in combination with zanubrutinib to evaluate its anticancer activity in people with chronic lymphocytic leukemia (CLL) and other B-cell malignancies. This research aims to understand how the combination affects disease control and response. The study is sponsored by Curis, Inc., focusing on new treatment options for CLL.

Who may be eligible for this chronic lymphocytic leukemia clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of chronic lymphocytic leukemia may be eligible. Participants must be currently taking zanubrutinib and meet specific response or progression criteria depending on their group. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic lymphocytic leukemia clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and related costs may vary and are not guaranteed to be covered. Participants should consider these factors when planning to join the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07271667

Phase 2 Study of Emavusertib with Zanubrutinib for Adults with Chronic Lymphocytic Leukemia and Other B-cell Cancers

Led by Curis, Inc. · Updated on 2026-06-12

108

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the combination of emavusertib and zanubrutinib to evaluate their anticancer activity in participants with chronic lymphocytic leukemia CLL and other B-cell malignancies. This phase 2 trial focuses on two groups Cohort 1 includes participants who have been on zanubrutinib for at least 12 months and show partial response with measurable residual disease, while Cohort 2 includes those with relapsed CLL who progressed on zanubrutinib. The study aims to assess treatment responses and disease control in these populations. Participants in both cohorts will receive oral doses of emavusertib twice daily alongside an approved dose of zanubrutinib. The study is divided into Part A, where participants receive one of two doses of emavusertib in combination with zanubrutinib, and Part B, which will enroll additional participants if Part A meets specific criteria. Treatment duration and dosing follow established schedules, with careful monitoring throughout the trial. Throughout the study, participants will be regularly assessed for response to treatment using measures such as undetectable measurable residual disease uMRD rate and overall response rate ORR up to approximately 23 months. Additional evaluations include duration of response, progression-free survival, overall survival, and monitoring of adverse events. Blood samples will be collected to measure drug concentrations. Participants are expected to comply with study visits and procedures during this treatment period.

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

Age: 18Years +

All Genders

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
Diagnosis of chronic lymphocytic leukemia confirmed by pathology
At least one measurable disease criterion per iwCLL guidelines
For Cohort 1: partial response or partial response with lymphocytosis and measurable residual disease positive, on zanubrutinib for at least 12 months, acceptable organ function
For Cohort 2: relapsed disease after zanubrutinib with no other standard options, progressed on zanubrutinib within 3 months prior to study entry, acceptable organ function
Creatine phosphokinase 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 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 malignancy unless in remission with life expectancy over 2 years and approved by sponsor
Active malignancy other than CLL requiring systemic therapy (exceptions possible with approval)
Presence of high-risk CLL TP53 mutations and 17P deletion
History of Grade 3 or higher 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 hematopoietic stem cell transplant within 60 days before treatment start or ongoing significant graft-versus-host disease
Systemic anticancer treatment within 21 days or 5 half-lives before treatment start except zanubrutinib
Use of medications with high risk of QT prolongation, peg-filgrastim, or St John's Wort within 7 days before treatment start
History or ongoing drug-induced pneumonitis
Stroke or intracranial hemorrhage within 6 months prior to treatment start
Requirement for warfarin or equivalent anticoagulation within 7 days before treatment start (low molecular weight heparin allowed)
Vaccination with live-attenuated vaccine within 4 weeks prior to treatment
Hypersensitivity to emavusertib, zanubrutinib, or their components
History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Intolerance to contrast agents
Recent major surgery within 28 days or minor surgery within 7 days before treatment
HIV positive or AIDS-related illness (exceptions may apply if controlled)
Hepatitis B or C infection within 6 months prior, unless viral load undetectable
Active systemic infections or recent severe infections requiring hospitalization or IV antibiotics
Other illnesses that would prevent safe study participation
Pregnant or breastfeeding women

Research Team

Ahmed Hamdy, MD

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Phase 2 Study of Emavusertib with Zanubrutinib for Adults with Chronic Lymphocytic Leukemia and Other B-cell Cancers

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria