Recruiting
Phase 3

NX-5948 vs. Pirtobrutinib

Sponsor:

Nurix Therapeutics, Inc.

Code:

NCT07516093

Conditions

B-cell Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NX-5948

Pirtobrutinib

Study Details

Brief 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.

Conditions

B-cell Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT07516093

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2033

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

620 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: NX-5948

experimental: Arm B: Pirtobrutinib

Interventions

NX-5948

Administered orally once daily

Pirtobrutinib

Administered orally once daily per prescribing information

Primary outcome measure

  • Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) [ Time Frame: Up to approximately 3.5 years ]
  • Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC [ Time Frame: Up to approximately 2.5 years ]

Central Contacts and Locations

Central contacts

Additional Site Contact Information

415-417-3418clinicaltrials@nurixtx.com

Locations

Central Georgia Cancer Care

Recruiting

Macon, Georgia, United States, 31210

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Hematology Oncology of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - West Texas

Recruiting

Midland, Texas, United States, 79124

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22201

More Information

Sponsor

Nurix Therapeutics, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • Degrader
  • B-cell malignancy
  • BTKi
  • Bexobrutideg
  • Pirtobrutinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nurix Therapeutics, Inc. on 2026-08-31.