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RECRUITING Phase 3 ClinicalTrials.gov

Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL

Sponsor: Nurix Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07516093

Registry updated: 2026-08-31
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Description

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.

Interventions

  • NX-5948 (Drug)
    Administered orally once daily
  • Pirtobrutinib (Drug)
    Administered orally once daily per prescribing information

Eligibility criteria

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.

Conditions

B-cell Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Locations

  • Central Georgia Cancer Care — Macon, Georgia, United States
  • Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
  • Hematology Oncology of Indiana — Indianapolis, Indiana, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Texas Oncology - West Texas — Midland, Texas, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record