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A study of emavusertib and zanubrutinib in patients with chronic lymphocytic leukemia and other B-cell cancers.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness of a combination treatment for individuals with Chronic Lymphocytic Leukemia and other B-cell malignancies, which are types of blood cancers that start in the white blood cells. The treatment involves using the drug emavusertib, also known by the code name CA-4948, together with zanubrutinib, an approved Bruton Tyrosine Kinase Inhibitor. This specific type of medicine works by targeting certain proteins that help cancer cells grow.

Participants in the study will take these medications by mouth in the form of coated tablets or capsules. The study aims to determine how well this combination of drugs works to reduce cancer cells in the body. During the study, medical professionals will monitor the response to the treatment and watch for any side effects that may occur while taking the medications.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
Once the study begins, emavusertib (taken as a coated tablet) and zanubrutinib (taken as either hard capsules or film-coated tablets) are administered via oral use.
Step 2
Medical assessments and monitoring
Regular physical examinations, checks of vital signs, and electrocardiograms (tests that record the electrical activity of the heart) are conducted.
laboratory values (blood tests) are monitored to track health and observe any treatment-emergent adverse events, which are side effects that occur during the study.
Step 3
Evaluation of treatment response
For those in cohort 1, the focus is on achieving undetectable measurable residual disease. This means checking if the cancer cells are low enough to not be detected in the peripheral blood mononuclear cells (a type of white blood cell found in the blood) using a specific test called the clonoseq assay. A bone marrow aspirate (a procedure to collect a sample of liquid from the bone marrow) is required to confirm a complete response and undetectable measurable residual disease.
For those in cohort 2, the focus is on the overall response rate. This measures the percentage of people who achieve a complete response (no detectable signs of cancer) or a partial response (a reduction in the size or spread of cancer) based on specific iwcll response criteria guidelines.

Who can join the trial?

15 criteria

You must be at least 18 years old and expected to live for at least 3 months.
For the first group of patients (Cohort 1), you must have Partial Response (PR) or Partial Response with Lymphocytosis (PR-L), which means your cancer has decreased in size but some cancer cells remain, and you must have Measurable Residual Disease (MRD+), which means there are still tiny amounts of cancer cells left in your body that can be detected by a special test called a ClonoSEQ assay.
For the first group of patients (Cohort 1), you must have been taking the medicine zanubrutinib for at least 12 months.
For the second group of patients (Cohort 2), your cancer must have relapsed, meaning it has come back or started growing again, and you must have already used or be unable to use standard medical treatments.
For the second group of patients (Cohort 2), you must be taking zanubrutinib and your cancer must have progressed (gotten worse) while taking it, without starting any other cancer treatments since.
Both groups must have acceptable organ function, meaning your heart, liver, lungs, and kidneys are working well enough according to the study rules.
Your Eastern Cooperative Oncology Group Performance Status must be 2 or less, which is a scale used to measure how well you can perform daily activities while living with cancer.
You must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL), a type of blood cancer, based on a tissue sample examined under a microscope.
You must have at least one area of measurable disease, which means there is a part of the cancer that doctors can clearly see and measure using specific medical guidelines.
Your creatine phosphokinase (CPK) levels, which is an enzyme in your blood that can indicate muscle damage, must be below a certain limit.
You must be able to undergo a contrast-enhanced computed tomography (CT) scan, which is a detailed X-ray image that uses a special dye to help see inside the body.
You must be able to swallow and keep oral medications (pills or liquids) in your stomach.
Women who are able to become pregnant must have a negative serum pregnancy test, meaning the blood test shows you are not pregnant.
Women who can become pregnant and men who have partners who can become pregnant must use highly effective birth control during the study and for 180 days after the last dose of treatment.
You must be able to understand and sign a written informed consent document, which is a paper that explains all the details of the study before you agree to join.

Who cannot join the trial?

20 criteria

Having another type of active cancer, unless it is currently in remission (a period where there are no signs or symptoms of the disease) and you are expected to live for more than 2 years.
Having Chronic Lymphocytic Leukemia (CLL) that includes high-risk genetic changes, specifically TP53 mutations or 17P deletion (changes in the DNA that make the cancer harder to treat).
A history of Stevens-Johnson syndrome or toxic epidermal necrolysis (severe, life-threatening skin reactions that cause blistering and peeling).
Being unable to tolerate a CT scan with contrast (a medical imaging test that uses a special dye to make body parts clearer).
Having had major surgery within the last 28 days or minor surgery within the last 7 days before starting the study.
Having a viral infection that meets specific study rules.
Having any other illness that would make it unsafe for you to participate in the study.
A history of Grade 3 or higher rhabdomyolysis (a serious condition where muscle tissue breaks down and releases protein into the blood) that has not fully healed.
Having previously received chimeric antigen receptor-T cell therapy (a type of immune system treatment where engineered cells are used to fight cancer).
Having taken investigational drugs (experimental medicines) within 28 days or a specific amount of time based on how long the drug stays in your body.
Having had an allogeneic hematopoietic stem cell transplant (a procedure where healthy blood-forming cells are given to a patient) within the last 60 days.
Having graft-versus-host disease (GVHD) (a condition where transplanted immune cells attack the recipient's body) that requires ongoing increases in immunosuppressive medications (drugs that lower the body's immune response).
Having received systemic anticancer treatment (cancer treatment that travels through the whole body) within 21 days, except for the medicine zanubrutinib, which can be continued until the day before the study starts.
Taking certain medicines within 7 days that increase the risk of prolonged QT interval or Torsades de Pointes (electrical problems in the heart that can cause dangerous irregular heartbeats).
Taking Peg-filgrastim (a medicine used to increase white blood cell counts) or St John’s Wort (a herbal supplement) within 7 days.
A history of or current drug-induced pneumonitis (inflammation of the lung tissue caused by medication).
Having a stroke (interruption of blood flow to the brain) or intracranial hemorrhage (bleeding inside the skull) within the last 6 months.
Needing anticoagulation (blood-thinning medication) such as warfarin or dual antiplatelet agents (medicines that prevent blood cells from sticking together) within a specific timeframe before the study starts.
Having received a live-attenuated vaccine (a vaccine that uses a weakened form of a germ) within the last 4 weeks.
A history of hypersensitivity or anaphylaxis (severe, life-threatening allergic reactions) to the study drugs or their excipients (inactive ingredients used to make the medicine).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera di Padova
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Padua, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
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Novara, Italy
Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain

Trial locations

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Investigated drugs

CA-4948
is an experimental medicine being tested to see how well it works at fighting cancer when used alongside another treatment.
Brukinsa
is an approved medication used to treat certain types of blood cancers by targeting specific proteins that help cancer cells grow.

What is already known about the treatment

Emavusertib
This medication is taken orally in the form of a coated tablet and is currently being studied in clinical trials for its potential anticancer effects. It belongs to a class of drugs known as kinase inhibitors and works by blocking specific proteins inside cells that help cancer grow and spread. It is being investigated for use in treating chronic lymphocytic leukemia and other types of blood cancers.
Zanubrutinib
This medicine is an approved treatment taken orally as either hard capsules or film-coated tablets for certain types of blood cancers. It belongs to a pharmacological group called Bruton tyrosine kinase inhibitors, which works by blocking a specific enzyme that cancer cells need to survive and multiply. This drug is widely used in medical practice to treat conditions like chronic lymphocytic leukemia and other B-cell malignancies.

Investigated diseases

Chronic Lymphocytic Leukemia
This is a type of cancer that affects the white blood cells known as lymphocytes. These abnormal cells build up in the blood, bone marrow, and lymph nodes. As the disease progresses, the buildup of these cells can interfere with the body's normal immune functions. The condition often develops slowly over time.
B-cell Malignancies
These are a group of cancers that originate from B-cells, which are a specific type of white blood cell responsible for making antibodies. The disease occurs when these cells undergo genetic changes that cause them to grow and multiply uncontrollably. This abnormal growth can lead to the accumulation of cells in various parts of the body. The progression depends on the specific type of B-cell involved.