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)
Start Date
10/15/2025
Completion Date
10/1/2030
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.
Detailed Description
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
Age Range: 18 years to No maximum
Interventions
NX-5948
Conditions
Locations
City of Hope
Duarte, California 91010
United States
Colorado Blood Institute
Denver, Colorado 80218
United States
University of Miami
Coral Gables, Florida 33146
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Fort Wayne Oncology and Hematology
Fort Wayne, Indiana 46804
United States
Hematology Oncology of Indiana
Indianapolis, Indiana 46260
United States
University of Iowa
Iowa City, Iowa 52242
United States
Maryland Oncology Hematology
Silver Spring, Maryland 20904
United States
Karmanos Cancer Center
Detroit, Michigan 48201
United States
Duke University
Durham, North Carolina 27705
United States
Novant Health Cancer Institute
Winston-Salem, North Carolina 27103
United States
University of Cincinnati
Cincinnati, Ohio 45221
United States
Oncology Hematology Care
Fairfield, Ohio 45014
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Texas Oncology - Center South
Austin, Texas 78705
United States
University of Utah
Salt Lake City, Utah 84112
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Oncology & Hematology Associates of Southwest VA
Norfolk, Virginia 23502
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
CHU de Nantes
Nantes, 44000
France
Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Italy
Ospedale San Raffaele S.r.l.
Milan, 20132
Italy
AUSL della Romagna UO Ematologia
Ravenna, 48121
Italy
Pratia Hematologia Sp. z o.o.
Katowice, 40-519
Poland
Pratia S.A.
Krakow, 30-225
Poland
Aidport Sp. z o.o.
Skorzewo, 60-185
Poland
Pratia Warszawa / Pratia MTZ
Warsaw, 02-172
Poland
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford OX3 9D
United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom