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Looking for participantsPhase2

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)

Sponsor: Nurix Therapeutics, Inc.

NCT ID: NCT07221500

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NX-5948 (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
NX-5948 — drug: Oral dose administered once daily.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
100
Started
2025-10-15
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia (cll)
  • • Phase2 - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukemia (cll)

Where?

  • • Headington - Oxford University Hospitals NHS Foundation Trust
  • • London - The Royal Marsden NHS Foundation Trust
  • • London - Sarah Cannon Research Institute UK, Limited
  • • Manchester - The Christie NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

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

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ measurable disease by radiographic assessment
  • ✓ for the study and is willing to participate

What the study is looking for

  • ✓Age: ≥ 18 years
  • ✓Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
  • ✓activity scale (ECOG) performance status of 0-2
  • ✓Participants with SLL must have cancer that can be measured on scans by radiographic assessment
  • ✓Adequate organ and bone marrow function

Who cannot take part

  • ✗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...
  • ✗Antibody therapy must stop at least 4 weeks before the first dose of the study treatment
  • ✗Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28...
  • ✗Use of systemic corticosteroids \>20 mg/day prednisone or equivalent within the 7 days before start of the study treatment...
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Where Is This Study? (4 UK sites)

Oxford University Hospitals NHS Foundation Trust

Headington OX3 9D, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute UK, Limited

London W1G 6AD, United Kingdom

Recruiting

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Additional Site Contact Information

Sponsor contact

CONTACT

415-417-3418 clinicaltrials@nurixtx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09