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)

Last updated: March 13, 2026
Sponsor: Nurix Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphocytic Leukemia, Chronic

Lymphoma

Chronic Lymphocytic Leukemia

Treatment

NX-5948

Clinical Study ID

NCT07221500
NX-5948-201
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: ≥ 18 years

  • Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis andsystemic 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-2inhibitor 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 purposeof the procedures required for the study and is willing to participate

Exclusion

Exclusion Criteria:

  • Known or suspected prolymphocytic leukemia or Richter's transformation beforeentering 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 isallowed, if they are not on the list of prohibited concomitant medications inthis study

  • Radiotherapy within 2 weeks of the first dose of study drug except for focalpalliative radiation

  • Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7days before start of study drug except for those used as premedication for radiodiagnostic 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 hematopoieticcell transplant <1 year prior to enrollment

  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomaticcerebrovascular events), stroke, or intracranial hemorrhage within 6 months ofplanned start of study drug

Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: NX-5948
Phase: 2
Study Start date:
October 15, 2025
Estimated Completion Date:
October 31, 2030

Study Description

The main purpose of this study is to test if NX-5948 works to treat patients with R/R CLL/SLL. NX-5948 is a BTK degrader and works by destroying the BTK protein to stop all its actions. This is different from a BTK inhibitor which works by blocking only the kinase action of BTK. This study aims to answer these questions:

  • How well does NX-5948 work to treat patients who have previously received a BTK inhibitor and a BCL-2 inhibitor?

  • How safe is NX-5948 and can patients take NX-5948 as long as they need to?

  • What is the amount of NX-5948 in the bloodstream over time when given to patients with CLL/SLL?

All patients in the study will receive NX-5948 orally until their cancer gets worse or if there are other reasons to stop taking NX-5948. Patients will have their cancer and other health check-ups regularly while they are taking NX-5948. If a patient's cancer has not gotten worse and they stop taking NX-5948, they will continue to have cancer check-ups until their cancer gets worse.

Connect with a study center

  • CHU de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes 2990969, 44000
    France

    Site Not Available

  • AUSL della Romagna UO Ematologia

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Pratia Hematologia Sp. z o.o.

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Pratia Hematologia Sp. z o.o.

    Katowice 3096472, 40-519
    Poland

    Site Not Available

  • Pratia S.A.

    Krakow, 30-225
    Poland

    Active - Recruiting

  • Pratia S.A.

    Krakow 3094802, 30-225
    Poland

    Site Not Available

  • Aidport Sp. z o.o.

    Skorzewo, 60-185
    Poland

    Active - Recruiting

  • Aidport Sp. z o.o.

    Skorzewo 3085749, 60-185
    Poland

    Site Not Available

  • Pratia Warszawa / Pratia MTZ

    Warsaw, 02-172
    Poland

    Active - Recruiting

  • Pratia Warszawa / Pratia MTZ

    Warsaw 756135, 02-172
    Poland

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford OX3 9D
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Headington 2647239, Oxford OX3 9D
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust

    London 2643743, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Colorado Blood Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Colorado Blood Institute

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Maryland Oncology Hematology

    Silver Spring 4369596, Maryland 4361885 20904
    United States

    Site Not Available

  • Novant Health Cancer Institute

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45221
    United States

    Active - Recruiting

  • Oncology Hematology Care

    Fairfield, Ohio 45014
    United States

    Active - Recruiting

  • Oncology Hematology Care

    Fairfield 4511283, Ohio 5165418 45014
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Oncology - Center South

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Oncology - Center South

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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