Phase 2 Study of Oral NX-5948 for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated with BTK and BCL-2 Inhibitors

What this Trial Is About

Researchers are evaluating NX-5948 bexobrutideg in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with both a Brutons Tyrosine Kinase BTK inhibitor and a B-cell lymphoma-2 BCL-2 inhibitor. This study aims to understand how well NX-5948 works as a treatment by destroying the BTK protein, which differs from BTK inhibitors that only block part of its activity. The study also assesses the safety of NX-5948 and its presence in the bloodstream over time. Participants will receive NX-5948 orally once daily in continuous 28-day cycles until their cancer worsens or other reasons require stopping treatment. During treatment, patients will have regular check-ups to monitor their cancer and overall health. If a patients cancer has not progressed and they stop taking NX-5948, they will continue to have cancer evaluations until progression occurs. Participation could last up to five years or longer if the disease remains stable. Throughout the study, researchers will measure the objective response rate without partial response with lymphocytosis, along with other outcomes like duration of response, progression-free survival, overall survival, quality of life, and safety through adverse event monitoring and laboratory tests. Assessments include regular health check-ups, quality of life questionnaires, and blood tests. The study is open-label and involves ongoing evaluation of the drugs effects and participant well-being for up to five years.

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)