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 now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

In brief

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.

Key facts

Study ID

NCT07221500

Run by

Nurix Therapeutics, Inc.

People needed

100

Starts

2025-10-15

Expected to finish

2030-10-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Scripps Health — San Diego, California, United States (enrolling)
• Colorado Blood Institute — Denver, Colorado, United States (enrolling)
• University of Miami — Coral Gables, Florida, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Fort Wayne Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
• Hematology Oncology of Indiana — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Maryland Oncology Hematology — Silver Spring, Maryland, United States (enrolling)
• Karmanos Cancer Center — Detroit, Michigan, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Novant Health Cancer Institute — Winston-Salem, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Oncology Hematology Care — Fairfield, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - Center South — Austin, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (enrolling)
• Oncology & Hematology Associates of Southwest VA — Norfolk, Virginia, United States (enrolling)
• Virginia Oncology Associates — Norfolk, Virginia, United States (enrolling)
• CHU de Nantes — Nantes, France (enrolling)
• Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.