NCT07516093RecruitingPhase 3
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
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)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 620 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 3 Aug 2026
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Nurix Therapeutics, Inc.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT07516093
- EU CT number
- 2025-524145-27-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 620
- From 3 Aug 2026 to the primary completion date, 31 Oct 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Fort Wayne Medical Oncology and Hematology Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
| Hematology Oncology of Indiana Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Central Georgia Cancer Care Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
| Texas Oncology - West Texas Coordinator of this site? Confirm its status | Midland | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.