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

Nurix Therapeutics

Status and phase: Not yet enrolling; Phase 3

Conditions: Small Lymphocytic Lymphoma; B-cell Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Pirtobrutinib; Drug: NX-5948

Study type: Interventional

Funder types: Industry

Identifiers

NCT07516093

NX-5948-306

2025-524145-27-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 620 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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620 participants in 2 patient groups

Arm A: NX-5948

Experimental group

Treatment:

Drug: NX-5948

Arm B: Pirtobrutinib

Experimental group

Treatment:

Drug: Pirtobrutinib