Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL (NCT07516093) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
620 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 one 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.
What they're measuring
1
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)