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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)
NCT07221500 · Nurix Therapeutics, Inc.
In plain English
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Official title
A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)
About this study
The main purpose of this study is to test if NX-5948 works to treat patients with R/R CLL/SLL. NX-5948 is a BTK degrader and works by destroying the BTK protein to stop all its actions. This is different from a BTK inhibitor which works by blocking only the kinase action of BTK. This study aims to answer these questions:
* 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.
Eligibility criteria
Inclusion Criteria:
* 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 treatment or in combination
* 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:
* 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
* 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 or autologous hematopoietic cell transplant \<1 year 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
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-15
Estimated completion: 2030-10
Last updated: 2026-04-14
Interventions
Drug: NX-5948
Primary outcomes
- • Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC) (Up to approximately 5 years)
Sponsor
Nurix Therapeutics, Inc. · industry
Contacts & investigators
ContactAdditional Site Contact Information · contact · clinicaltrials@nurixtx.com · 415-417-3418
InvestigatorNurix Study Director · study_director, Nurix Therapeutics, Inc.
All locations (20)
Colorado Blood InstituteRecruiting
Denver, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Maryland Oncology HematologyRecruiting
Silver Spring, Maryland, United States
Novant Health Cancer InstituteRecruiting
Winston-Salem, North Carolina, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
Oncology Hematology CareRecruiting
Fairfield, Ohio, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Center SouthRecruiting
Austin, Texas, United States
Virginia Cancer Specialists, PCRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
CHU de NantesRecruiting
Nantes, France
AUSL della Romagna UO EmatologiaRecruiting
Ravenna, Italy
Pratia Hematologia Sp. z o.o.Recruiting
Katowice, Poland
Pratia S.A.Recruiting
Krakow, Poland
Aidport Sp. z o.o.Recruiting
Skorzewo, Poland
Pratia Warszawa / Pratia MTZRecruiting
Warsaw, Poland
Oxford University Hospitals NHS Foundation TrustRecruiting
Headington, Oxford, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom