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)
NCT ID: NCT07221500
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-10-15
2030-10-31
Brief Summary
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Detailed Description
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* How well does NX-5948 work to treat patients who have previously received a BTK inhibitor and a BCL-2 inhibitor?
* How safe is NX-5948 and can patients take NX-5948 as long as they need to?
* What is the amount of NX-5948 in the bloodstream over time when given to patients with CLL/SLL?
All patients in the study will receive NX-5948 orally until their cancer gets worse or if there are other reasons to stop taking NX-5948. Patients will have their cancer and other health check-ups regularly while they are taking NX-5948. If a patient's cancer has not gotten worse and they stop taking NX-5948, they will continue to have cancer check-ups until their cancer gets worse.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NX-5948
NX-5948
Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.
Interventions
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NX-5948
Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.
Eligibility Criteria
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Inclusion Criteria
* Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for systemic treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Must have received both a BTK inhibitor and a BCL-2 inhibitor
* 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 Criteria
* 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
* Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation
* 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
* 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
18 Years
ALL
No
Sponsors
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Nurix Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nurix Study Director
Role: STUDY_DIRECTOR
Nurix Therapeutics, Inc.
Locations
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CHU de Nantes
Nantes, , France
Pratia Hematologia Sp. z o.o.
Katowice, , Poland
Pratia S.A.
Krakow, , Poland
Aidport Sp. z o.o.
Skorzewo, , Poland
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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NX-5948-201
Identifier Type: -
Identifier Source: org_study_id