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

April 8, 2026 updated by: Nurix Therapeutics, Inc.

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NX-5948 + venetoclax
Drug: NX-5948
Administered orally once daily as a capsule
Other Names:
  • bexobrutideg
Drug: venetoclax
Administered orally once daily as a tablet per prescribing information
Experimental: NX-5948 + venetoclax + rituximab
Drug: NX-5948
Administered orally once daily as a capsule
Other Names:
  • bexobrutideg
Drug: venetoclax
Administered orally once daily as a tablet per prescribing information
Drug: rituximab
Administered as an intravenous (IV) infusion per prescribing information
Experimental: NX-5948 + venetoclax + obinutuzumab
Drug: NX-5948
Administered orally once daily as a capsule
Other Names:
  • bexobrutideg
Drug: venetoclax
Administered orally once daily as a tablet per prescribing information
Drug: obinutuzumab
Administered as an IV infusion per prescribing information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events
Time Frame: Up to approximately 7 years
Up to approximately 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic profile of NX-5948
Time Frame: Up to approximately 1 year
NX-5948 concentrations in blood samples
Up to approximately 1 year
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
Up to approximately 7 years
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
Up to approximately 7 years
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
Up to approximately 7 years
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.
Up to approximately 7 years
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
Up to approximately 7 years
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
Up to approximately 7 years
Pharmacokinetic profile of venetoclax
Time Frame: Up to approximately 1 year
Venetoclax concentrations in blood samples
Up to approximately 1 year
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
Baseline and up to approximately 27 months
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
Baseline and up to approximately 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nurix Therapeutics, Inc.

Investigators

  • Study Director: Study Director, Nurix Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2033

Study Completion (Estimated)

May 1, 2033

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX-5948-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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