Back to search results

A Study of NX-5948 for Relapsed/Refractory CLL/SLL

This study is testing a new oral medication called NX-5948 for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. You might be able to join if you've already been treated with certain types of BTK inhibitors (like covalent and non-covalent BTK inhibitors) and a BCL-2 inhibitor. NX-5948 works by destroying a protein called BTK, which is different from how some other medicines block it. The main goal is to see how well NX-5948 treats your condition and if it's safe. The study plans to enroll about 100 people, and the status of recruitment is currently unclear. Success will be measured by how many patients respond to the treatment, as determined by an independent review committee, over approximately 5 years.

Study design
This is an interventional study, meaning all participants will receive the study drug NX-5948. It aims to enroll about 100 participants.
What's involved
You would take NX-5948 orally once daily in continuous 28-day cycles. You will have regular check-ups while taking the medication, and potentially after stopping if your cancer hasn't worsened.
Compensation
Not stated in the trial record.
Follow-up
You could be followed for up to approximately 5 years to see how well the treatment works, and possibly longer if your disease does not progress.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221500

A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Nurix Therapeutics, Inc.
~100 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:NX-5948

At a glance

Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC)
Measured over Up to approximately 5 years

Conditions

Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

37 sites across 20 states
Ohio4
Italy4
Poland4
California3
Virginia3
Florida2
Indiana2
North Carolina2

Study leadership

  • Nurix Study Director · STUDY_DIRECTOR · Nurix Therapeutics, Inc.

Who to contact

Additional Site Contact Information
[email protected]
415-417-3418
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age: ≥ 18 years
Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen
Participants with SLL must have measurable disease by radiographic assessment
Adequate organ and bone marrow function
Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate

Exclusion

Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug
Antibody therapy must stop at least 4 weeks before the first dose of study drug
No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study
Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug
Use of systemic corticosteroids \>20 mg/day prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast
Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug
Previously treated with a BTK degrader
Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug

What this trial measures

  • Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC)Up to approximately 5 years

    The percentage of participants with response as determined according to 2018 International Workshop on CLL (iwCLL) guidelines. Response will include complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), and nodular PR.