Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL

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.

Eligibility

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 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.

Conditions4

Interventions2

Locations6 sites

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Related trials

• A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201) — Nurix Therapeutics, Inc.
• A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies — Nurix Therapeutics, Inc.
• Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies — Nurix Therapeutics, Inc.
• A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure. — Australasian Leukaemia and Lymphoma Group
• Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib — Peter MacCallum Cancer Centre, Australia
• Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL — The First Affiliated Hospital of Soochow University
• A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma — BeOne Medicines
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