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Chronic Lymphocytic Leukemia (CLL)Phase 2NCT07221500

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)

A Phase 2 study testing NX-5948 in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Nurix Therapeutics, Inc. at 43 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NX-5948
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
43 sitesin 5 countries
Study dates
15 Oct 2025to Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen
  • Participants with SLL must have 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

Who cannot join

  • 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
  • Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug
  • 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
Show all 11Show fewer
  • 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 allogeneic or autologous hematopoietic cell transplant within the past 90 days 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
  • Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Trial locations and contacts

43 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Additional Site Contact Information contact

415-417-3418

clinicaltrials@nurixtx.com

43 sites in 5 countries

United States28 sites, 28 recruiting

  • Texas Oncology - Center South

    Austin, Texas, 78705

    Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45221

    Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • University of Miami

    Coral Gables, Florida, 33146

    Recruiting

  • Colorado Blood Institute

    Denver, Colorado, 80218

    Recruiting

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Duke University

    Durham, North Carolina, 27705

    Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Recruiting

  • Oncology Hematology Care

    Fairfield, Ohio, 45014

    Recruiting

  • Fort Wayne Oncology and Hematology

    Fort Wayne, Indiana, 46804

    Recruiting

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Oncology & Hematology Associates of Southwest VA

    Norfolk, Virginia, 23502

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • Banner MD Anderson Cancer Center

    Phoenix, Arizona, 85012

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

  • Scripps Health

    San Diego, California, 92121

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

    Recruiting

  • Novant Health Cancer Institute

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

    Recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori

    Meldola (FC), 47014

    Recruiting

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

    Recruiting

  • AUSL della Romagna UO Ematologia

    Ravenna, 48121

    Recruiting

Other trials in Italy

Poland4 sites, 4 recruiting

  • Pratia Hematologia Sp. z o.o.

    Katowice, 40-519

    Recruiting

  • Pratia S.A.

    Krakow, 30-225

    Recruiting

  • Aidport Sp. z o.o.

    Skorzewo, 60-185

    Recruiting

  • Pratia Warszawa / Pratia MTZ

    Warsaw, 02-172

    Recruiting

Other trials in Poland

United Kingdom4 sites, 4 recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford, OX3 9D

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute UK, Limited

    London, W1G 6AD

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

France1 site, 1 recruiting

  • CHU de Nantes

    Nantes, 44000

    Recruiting

Other trials in France

About this study

Official title: A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

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.

Read the detailed 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.

Being tested
NX-5948
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)
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NX-5948Drug

    Also called Bexobrutideg

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

Study groups in NCT07221500
Study groupRoleWhat they receive
NX-5948ExperimentalNot described
Receives: Drug: NX-5948

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 5 years

Secondary outcomes (13)

  1. Objective response rate with PR-L as determined by IRC

    The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR.

    Measured: Up to approximately 5 years

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

    The percentage of participants with response as determined according to 2018 iwCLL guidelines. Response will include CR/CRi, PR, and nodular PR.

    Measured: Up to approximately 5 years

  3. Duration of response as determined by IRC and by investigator

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

    Measured: Up to approximately 5 years

  4. Progression-free survival as determined by IRC and by investigator

    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

    Measured: Up to approximately 5 years

  5. Complete response rate as determined by IRC and by investigator

    The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines

    Measured: Up to approximately 5 years

  6. Time to response as determined by IRC and by investigator

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

    Measured: Up to approximately 5 years

  7. Overall survival

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

    Measured: Up to approximately 5 years

  8. Number of participants with treatment-emergent adverse events (TEAEs), Grade 3 or higher TEAEs, serious adverse events, and TEAEs leading to study drug discontinuation

    Measured: Up to approximately 3 years

  9. Number of participants with clinically significant changes from baseline in laboratory parameters

    Laboratory parameters may include hematology, clinical chemistry, and urinalysis

    Measured: Up to approximately 3 years

  10. Number of participants with clinically significant changes from baseline in vital signs

    Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature

    Measured: Up to approximately 3 years

  11. Pharmacokinetic profile of NX-5948

    NX-5948 concentrations in blood samples

    Measured: Up to approximately 1 year

  12. 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)

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

    Measured: Baseline and up to approximately 5 years

  13. Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)

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

    Measured: Baseline and up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2025
  2. Study start15 Oct 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07221500
Sponsor's protocol ID
NX-5948-201
Status last verified
Oct 2026
First submitted
24 Oct 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NX-5948 in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Nurix Therapeutics, Inc. at 43 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Italy, Poland, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Additional Site Contact Information (415-417-3418, clinicaltrials@nurixtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07221500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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