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Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has returned or not responded to previous treatments. These are types of blood cancers that affect certain white blood cells. The study will test a new medication called NX-5948, which is taken as a capsule by mouth, in patients who have already been treated with two specific types of cancer medicines: a Bruton's Tyrosine Kinase inhibitor and a B-cell Lymphoma-2 inhibitor.

The purpose of this research is to determine how well NX-5948 works in treating adults with CLL or SLL that has come back or not responded to previous treatments. During the study, participants will receive NX-5948 capsules daily. The maximum daily dose that may be given is 600 milligrams, and treatment may continue for up to 28 days per treatment cycle.

Throughout the study, doctors will monitor participants' health through regular check-ups and various medical tests. They will look at how the cancer responds to the treatment and keep track of any side effects that may occur. The study will collect information about how long the treatment effects last and how it affects participants' overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be assessed based on specific criteria, including confirmation of relapsed/refractory CLL/SLL (types of blood cancer)

    Medical tests will be performed to verify your organ and bone marrow function

    Your previous treatment history will be reviewed to confirm you have received both a BTK inhibitor and a BCL-2 inhibitor

  2. Step 2

    Treatment initiation

    You will begin taking NX-5948 in capsule form by mouth

    Your disease will be measured through radiographic assessment before starting treatment

  3. Step 3

    Ongoing monitoring

    Regular assessments will track your response to treatment

    Blood tests will be conducted to measure NX-5948 levels in your blood

    Your vital signs and laboratory values will be monitored throughout the study

    Any side effects or health changes will be documented

  4. Step 4

    Response evaluation

    Your response to treatment will be evaluated by both study doctors and independent reviewers

    Regular scans will be performed to measure how your disease responds to treatment

    The time it takes for your disease to respond will be recorded

  5. Step 5

    Long-term follow-up

    Your health status will continue to be monitored even after completing treatment

    The duration of your response to treatment will be tracked

    Your overall survival will be monitored throughout the study period

Who can join the trial?

7 criteria

  • Must be 18 years of age or older
  • Must have confirmed relapsed/refractory CLL/SLL (chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned or stopped responding to previous treatments) that requires treatment according to established medical criteria
  • Must have an ECOG performance status of 0-2 (a measure of a person's ability to perform daily activities and self-care, where 0 means fully active and 2 means able to do light activities but unable to work)
  • Must have previously received treatment with both:
    • a BTK inhibitor (a type of medication that blocks specific proteins in cancer cells)
    • a BCL-2 inhibitor (a type of medication that helps trigger cancer cell death)
    • Must have disease that can be measured by imaging tests (such as CT scans)
    • Must have adequate organ and bone marrow function (meaning your major organs and blood-forming cells are working well enough)

Who cannot join the trial?

14 criteria

  • Prior diagnosis of Richter's transformation (a rare condition where CLL changes into an aggressive lymphoma)
  • Active or uncontrolled autoimmune conditions (diseases where the body's immune system attacks its own tissues)
  • History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or localized cancers
  • Known active central nervous system involvement by leukemia or lymphoma
  • Major surgery within 4 weeks before starting the study treatment
  • Significant heart problems, including:
    • Heart attack within the past 6 months
    • Uncontrolled irregular heartbeat
    • Severe heart failure
    • Active, uncontrolled infections requiring treatment
    • Known infection with HIV, hepatitis B, or hepatitis C
    • Pregnancy or breastfeeding
    • Unable to swallow oral medications
    • Current participation in other investigational drug studies
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

NX-5948 is an investigational medication being studied for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is designed to work in patients whose cancer has returned or become resistant to previous treatments. This medication is being tested in patients who have already been treated with two other types of cancer medications: BTK inhibitors and BCL-2 inhibitors. NX-5948 is taken orally and represents a new approach to treating these blood cancers.

What is already known about the treatment

NX-5948 – An investigational drug being studied in clinical trials for the treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) in patients who have previously been treated with BTK inhibitors and BCL-2 inhibitors. This novel therapeutic agent targets specific molecular pathways involved in blood cancer progression, representing a potential new treatment option for patients who have not responded adequately to existing therapies. While the specific method of administration is still under investigation in the current Phase 2 clinical trial, the drug is being evaluated in adult patients to determine its efficacy and safety profile according to established international guidelines.

Investigated diseases

  • Chronic Lymphocytic Leukemia (CLL)

    A slow-growing blood cancer that affects white blood cells called lymphocytes. The abnormal lymphocytes gradually increase in number, primarily in the blood and bone marrow. Over time, these cells can spread to the lymph nodes, liver, and spleen, causing them to enlarge. CLL typically develops over months or years, and some people may not experience symptoms in the early stages.

  • Small Lymphocytic Lymphoma (SLL)

    A type of lymphoma that is essentially the same disease as CLL but manifests differently in the body. In SLL, the abnormal lymphocytes mainly accumulate in the lymph nodes rather than in the blood and bone marrow. The disease develops slowly, and the abnormal cells can cause lymph nodes to become enlarged. SLL and CLL are considered different manifestations of the same condition.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521088-10-00Protocol codeNX-5948-201Estimated enrolment110 patientsSponsorNurix Therapeutics Inc.

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