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)
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 treatment or in combination * 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…
Interventions
- DrugNX-5948
Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.
Locations (20)
- Colorado Blood InstituteDenver, Colorado
- Florida Cancer SpecialistsSarasota, Florida
- University of IowaIowa City, Iowa
- Maryland Oncology HematologySilver Spring, Maryland
- Novant Health Cancer InstituteWinston-Salem, North Carolina
- University of CincinnatiCincinnati, Ohio