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)

NCT07221500 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NX-5948-201
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 20

Brief Summary

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.

Conditions

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Keywords

BTK Degrader; BTK Inhibitor; BCL-2 Inhibitor; B-cell Malignancy; Lymphoma; Bruton's Tyrosine Kinase; NX-5948; Targeted Protein Degradation; Chimeric Targeting Molecule (CTM); Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Outcome Measures

Primary Outcomes (1)

• Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC)

  The percentage of participants with response as determined according to 2018 International Workshop on CLL (iwCLL) guidelines. Response will include complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), and nodular PR.

  Up to approximately 5 years

Secondary Outcomes (13)

• Objective response rate with PR-L as determined by IRC

  Up to approximately 5 years

• Objective response rate with and without PR-L as determined by investigator

  Up to approximately 5 years

• Duration of response as determined by IRC and by investigator

  Up to approximately 5 years

• Progression-free survival as determined by IRC and by investigator

  Up to approximately 5 years

• Complete response rate as determined by IRC and by investigator

  Up to approximately 5 years

Study Arms (1)

NX-5948

EXPERIMENTAL

Drug: NX-5948

Interventions

NX-5948 DRUG

Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.

Also known as: Bexobrutideg

NX-5948

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years
• Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of treatment or in combination
• Measurable disease by radiographic assessment
• Adequate organ and bone marrow function
• Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate

You may not qualify if:

• Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
• Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug
• Antibody therapy must stop at least 4 weeks before the first dose of study drug
• No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study
• 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 before start of study drug except for those used as premedication for radio diagnostic contrast
• Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug
• Previously treated with a BTK degrader
• Previous chimeric antigen receptor (CAR) T-cell therapy or autologous hematopoietic cell transplant \<1 year prior to enrollment
• Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (20)

Colorado Blood Institute

Denver, Colorado, 80218, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Maryland Oncology Hematology

Silver Spring, Maryland, 20904, United States

RECRUITING

Novant Health Cancer Institute

Winston-Salem, North Carolina, 27103, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45221, United States

RECRUITING

Oncology Hematology Care

Fairfield, Ohio, 45014, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Center South

Austin, Texas, 78705, United States

RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

CHU de Nantes

Nantes, 44000, France

RECRUITING

AUSL della Romagna UO Ematologia

Ravenna, 48121, Italy

RECRUITING

Pratia Hematologia Sp. z o.o.

Katowice, 40-519, Poland

RECRUITING

Pratia S.A.

Krakow, 30-225, Poland

RECRUITING

Aidport Sp. z o.o.

Skorzewo, 60-185, Poland

RECRUITING

Pratia Warszawa / Pratia MTZ

Warsaw, 02-172, Poland

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Headington, Oxford, OX3 9D, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Nurix Study Director

  Nurix Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Additional Site Contact Information

CONTACT

415-417-3418; clinicaltrials@nurixtx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (3); US (11); PL (4); IT (1)