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

Purpose

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.

Conditions

  • B-cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: NX-5948
  • Drug: NX-5948
    Administered orally once daily
    Other names:
    • Bexobrutideg
Experimental
Arm B: Pirtobrutinib
  • Drug: Pirtobrutinib
    Administered orally once daily per prescribing information
    Other names:
    • JAYPIRCA

Recruiting Locations

Central Georgia Cancer Care
Macon, Georgia 31210

Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804

Hematology Oncology of Indiana
Indianapolis, Indiana 46260

SCRI Oncology Partners
Nashville, Tennessee 37203

Texas Oncology - West Texas
Midland, Texas 79124

Virginia Cancer Specialists
Fairfax, Virginia 22201

More Details

Status
Recruiting
Sponsor
Nurix Therapeutics, Inc.

Study Contact

Additional Site Contact Information
415-417-3418
clinicaltrials@nurixtx.com