Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNurix Therapeutics, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NX-5948
- Pirtobrutinib
Treatment groups
620 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov