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NCT07520006PHASE1, PHASE2Recruiting

Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

Nurix Therapeutics, Inc.

Start Date

8/1/2026

Completion Date

5/1/2033

Summary

The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Detailed Description

Bexobrutideg is an investigational drug designed to target a protein called Bruton tyrosine kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. Bexobrutideg is a protein degrader, which means it finds and destroys the BTK in the cell. Venetoclax, rituximab, and obinutuzumab are approved medications that are used to treat CLL/SLL. The study will look at: * How safe bexobrutideg is for patients with CLL or SLL when taken with these other treatments * The effects of bexobrutideg in the body when taken with these other treatments * How well bexobrutideg treats CLL or SLL when taken with these other treatments

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate organ and bone marrow function * Measurable disease by computed tomography (CT) per iwCLL * For R/R CLL/SLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi) * For 1L CLL/SLL, confirmed previously untreated CLL/SLL with a clinical indication for systemic treatment that meets iwCLL criteria * Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate 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 * Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation * Use of systemic corticosteroids (\>20 mg/day prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast * Previously treated with a BTK degrader * Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment * Known central nervous system (CNS) lymphoma or leukemia * 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.

Interventions

DRUG

NX-5948

DRUG

venetoclax

DRUG

rituximab

DRUG

obinutuzumab

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Conditions

B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Locations

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

University of Miami

Coral Gables, Florida 33146

United States

Oncology Associates of Oregon

Eugene, Oregon 97401

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology - Northeast

Tyler, Texas 75702

United States