NCT07516093PHASE3Recruiting
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
Nurix Therapeutics, Inc.
Start Date
8/3/2026
Completion Date
8/1/2033
Summary
The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.
Eligibility Criteria
Age Range: 18 years to No maximum
Key Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate organ and bone marrow function
* Confirmed diagnosis of CLL/SLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment
* Received at least 1 prior line of therapy for CLL/SLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi
* Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL
Key Exclusion Criteria:
* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment
* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment
* Ongoing systemic corticosteroids ≥10 mg/day prednisone or equivalent
* Previously treated with a BTK degrader or a noncovalent BTKi
* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment
* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Interventions
DRUG
NX-5948
DRUG
Pirtobrutinib
Conditions
B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Locations
Central Georgia Cancer Care
Macon, Georgia 31210
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
Hematology Oncology of Indiana
Indianapolis, Indiana 46260
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Texas Oncology - West Texas
Midland, Texas 79124
United States
Virginia Cancer Specialists
Fairfax, Virginia 22201
United States