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

Sponsor: Nurix Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07516093

This study assesses the efficacy and safety of NX-5948 versus pirtobrutinib in R/R CLL/SLL patients post-cBTKi treatment. Eligible participants must have an ECOG status of 0-2, adequate organ function, and confirmed CLL/SLL diagnosis per iwCLL 2018 criteria. Interventions include daily oral administration of NX-5948 or pirtobrutinib.

Patient Parameters

Program Overview

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

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.

Locations

FACILITYZIPCITYSTATE
Central Georgia Cancer Care31210MaconGeorgia
Fort Wayne Medical Oncology and Hematology46804Fort WayneIndiana
Hematology Oncology of Indiana46260IndianapolisIndiana
SCRI Oncology Partners37203NashvilleTennessee
Texas Oncology - West Texas79124MidlandTexas
Virginia Cancer Specialists22201FairfaxVirginia

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