NCT07516093 · Nurix Therapeutics, Inc.
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
What this study is about
The study will evaluate the effectiveness 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.
View original scientific 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
DRUG
NX-5948
Administered orally once daily
DRUG
Pirtobrutinib
Administered orally once daily per prescribing information
Primary outcome measures
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Time frame: Up to approximately 3.5 years
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC
Time frame: Up to approximately 2.5 years
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Macon, Georgia
- Fort Wayne, Indiana
- Indianapolis, Indiana
- Nashville, Tennessee
- Midland, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations