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)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope
RECRUITING
Duarte
Colorado
Colorado Blood Institute
RECRUITING
Denver
Florida
University of Miami
RECRUITING
Coral Gables
Florida Cancer Specialists
RECRUITING
Sarasota
Iowa
University of Iowa
RECRUITING
Iowa City
Indiana
Fort Wayne Oncology and Hematology
RECRUITING
Fort Wayne
Hematology Oncology of Indiana
RECRUITING
Indianapolis
Maryland
Maryland Oncology Hematology
RECRUITING
Silver Spring
North Carolina
Duke University
RECRUITING
Durham
Novant Health Cancer Institute
RECRUITING
Winston-salem
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Oncology Hematology Care
RECRUITING
Fairfield
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - Center South
RECRUITING
Austin
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Oncology & Hematology Associates of Southwest VA
RECRUITING
Norfolk
Virginia Oncology Associates
RECRUITING
Norfolk
Other Locations
France
CHU de Nantes
RECRUITING
Nantes
Italy
Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola