What is the Purpose of this Study?
The purpose of this study is to determine whether an experimental drug called NX-5948 (bexobrutideg) is safe and effective in treating adults who have relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Relapsed or refractory means that CLL/SLL has either come back or did not respond after treatment. Participants must have previously received 3 different standard types of medications for CLL/SLL. Study procedures include daily oral administration of the bexobrutideg, blood draws, questionnaires, electrocardiograms, and computed tomography or magnetic resonance imaging. Researchers will also measure the amount of bexobrutideg in the blood at various times. Bexobrutideg is a medicine designed to target a protein called bruton tyrosine kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. Bexobrutideg works by breaking down BTK and acts like a protein degrader, which means that it finds and destroys specific proteins like BTK in the cell.
Eligibility
- * 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
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy
More about this Clinical Trial
What is the full name of this clinical trial?
NX-5948-201: Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to a Bruton s Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor