RECRUITING Phase 2 ClinicalTrials.gov

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)

Sponsor: Nurix Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07221500

Registry updated: 2026-09-17

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Description

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.

Interventions

NX-5948 (Drug)
Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.

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 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 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 * 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 Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Conditions

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

Locations

Banner MD Anderson Cancer Center — Phoenix, Arizona, United States
City of Hope — Duarte, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
Scripps Health — San Diego, California, United States
Colorado Blood Institute — Denver, Colorado, United States
University of Miami — Coral Gables, Florida, United States
Florida Cancer Specialists — Sarasota, Florida, United States
Fort Wayne Oncology and Hematology — Fort Wayne, Indiana, United States
Hematology Oncology of Indiana — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, United States
Maryland Oncology Hematology — Silver Spring, Maryland, United States
Karmanos Cancer Center — Detroit, Michigan, United States
Duke University — Durham, North Carolina, United States
Novant Health Cancer Institute — Winston-Salem, North Carolina, United States
University of Cincinnati — Cincinnati, Ohio, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
Oncology Hematology Care — Fairfield, Ohio, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
Texas Oncology - Center South — Austin, Texas, United States
University of Utah — Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
Oncology & Hematology Associates of Southwest VA — Norfolk, Virginia, United States
Virginia Oncology Associates — Norfolk, Virginia, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States
The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
CHU de Nantes — Nantes, France
Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna, Italy
Ospedale San Raffaele S.r.l. — Milan, Italy
AUSL della Romagna UO Ematologia — Ravenna, Italy
Pratia Hematologia Sp. z o.o. — Katowice, Poland
Pratia S.A. — Krakow, Poland
Aidport Sp. z o.o. — Skorzewo, Poland
Pratia Warszawa / Pratia MTZ — Warsaw, Poland
Oxford University Hospitals NHS Foundation Trust — Headington, Oxford, United Kingdom
The Royal Marsden NHS Foundation Trust — London, United Kingdom
Sarah Cannon Research Institute UK, Limited — London, United Kingdom
The Christie NHS Foundation Trust — Manchester, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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