RecruitingRecruiting
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
NCT07516093 · Nurix Therapeutics, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
About this study
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
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 target: 620 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-08-03
Estimated completion: 2033-08
Last updated: 2026-08-31
Interventions
Drug: NX-5948Drug: Pirtobrutinib
Primary outcomes
- • Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) (Up to approximately 3.5 years)
- • Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC (Up to approximately 2.5 years)
Sponsor
Nurix Therapeutics, Inc. · industry
Contacts & investigators
ContactAdditional Site Contact Information · contact · clinicaltrials@nurixtx.com · 415-417-3418
InvestigatorStudy Director · study_director, Nurix Therapeutics, Inc.
All locations (6)
Central Georgia Cancer CareRecruiting
Macon, Georgia, United States
Fort Wayne Medical Oncology and HematologyRecruiting
Fort Wayne, Indiana, United States
Hematology Oncology of IndianaRecruiting
Indianapolis, Indiana, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - West TexasRecruiting
Midland, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States