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NCT Number: NCT07520006

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

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).

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Key information

Conditions

B-cell Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NX-5948

Drug

Administered orally once daily as a capsule

Other names: bexobrutideg

Venetoclax

Drug

Administered orally once daily as a tablet per prescribing information

Rituximab

Drug

Administered as an intravenous (IV) infusion per prescribing information

Obinutuzumab

Drug

Administered as an IV infusion per prescribing information

Primary outcomes

  1. Number of participants with treatment-emergent adverse events

    Time frame: Up to approximately 7 years

Secondary outcomes

  1. Objective response rate as determined by investigator

    Time frame: Up to approximately 7 years

    The percentage of participants with response as determined according to 2018 iwCLL guidelines; response includes complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), PR with lymphocytosis (PR-L), and nodular PR

  2. Duration of response as determined by investigator

    Time frame: Up to approximately 7 years

    Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier

  3. Progression-free survival as determined by investigator

    Time frame: Up to approximately 7 years

    Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier

  4. Complete response rate as determined by investigator

    Time frame: Up to approximately 7 years

    The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines; includes CR + CRi for participants with CLL.

  5. Time to response as determined by investigator

    Time frame: Up to approximately 7 years

    Time from the start date of study treatment to the date of the first assessment of a response

  6. Overall survival

    Time frame: Up to approximately 7 years

    Time from the start date of study treatment to the date of death from any cause

  7. Pharmacokinetic profile of NX-5948

    Time frame: Up to approximately 1 year

    NX-5948 concentrations in blood samples

  8. Pharmacokinetic profile of venetoclax

    Time frame: Up to approximately 1 year

    Venetoclax concentrations in blood samples

  9. Change from baseline in Global Health Status/Quality of Life on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Baseline and up to approximately 27 months

    Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30 questionnaire to assess the overall quality of life

  10. Change from baseline in European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)

    Time frame: Baseline and up to approximately 27 months

    Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Additional Site Contact Information

CONTACT

[email protected]

415-417-3418

Sponsors and collaborators

Lead sponsor

Nurix Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Apr 9, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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