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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)
Sponsor: Nurix Therapeutics, Inc.
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-10-15
Completion Date
2030-10
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
NX-5948
Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.
Locations (18)
Colorado Blood Institute
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oncology Hematology Care
Fairfield, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - Center South
Austin, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
CHU de Nantes
Nantes, France
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
The Christie NHS Foundation Trust
Manchester, United Kingdom