Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
Sponsor: Nurix Therapeutics, Inc.
ClinicalTrials ID:NCT07516093
This study assesses the efficacy and safety of NX-5948 versus pirtobrutinib in R/R CLL/SLL patients post-cBTKi treatment. Eligible participants must have an ECOG status of 0-2, adequate organ function, and confirmed CLL/SLL diagnosis per iwCLL 2018 criteria. Interventions include daily oral administration of NX-5948 or pirtobrutinib.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Central Georgia Cancer Care | 31210 | Macon | Georgia |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| Hematology Oncology of Indiana | 46260 | Indianapolis | Indiana |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - West Texas | 79124 | Midland | Texas |
| Virginia Cancer Specialists | 22201 | Fairfax | Virginia |
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