ClinicalTrials.gg
RecruitingNCT07221500Updated Nov 3, 2026

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 interventional study of NX-5948 in Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), sponsored by Nurix Therapeutics, Inc.. Recruiting at 43 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Nurix Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Nov 3, 20263 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

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.

02

Conditions studied

  • 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)
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 100 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Nurix Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: ≥ 18 years
  • Confirmed CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
  • (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 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 by radiographic assessment
  • Adequate organ and bone marrow function
  • Must sign an form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate

Exclusion criteria

Exclusion Criteria:

  • Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
  • 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 >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 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 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.

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    NX-5948

    Drug: NX-5948

Interventions

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

    Also known as: Bexobrutideg

06

What researchers measure

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.

    Time frame: Up to approximately 5 years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 5 years

  7. Overall survival

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 3 years

  11. Pharmacokinetic profile of NX-5948

    NX-5948 concentrations in blood samples

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and up to approximately 5 years

07

Study locations

43 of 43 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added
Show 3 added (2 Italy, 1 United States)
  • University of Virginia Medical Center · Charlottesville, United States
  • ASST degli Spedali Civili di Brescia · Brescia, Italy
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori · Meldola (FC), Italy
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    3 sites added
    Show 3 added (2 Italy, 1 United States)
    • University of Virginia Medical Center · Charlottesville, United States
    • ASST degli Spedali Civili di Brescia · Brescia, Italy
    • IRCCS - Istituto Romagnolo per lo Studio dei Tumori · Meldola (FC), Italy
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07221500
Lead sponsor
Nurix Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 28, 2025
Start date
Oct 15, 2025
Primary completion
Jan 2028 (estimated)
Completion
Oct 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Additional Site Contact Information
Contact
clinicaltrials@nurixtx.com
415-417-3418
Nurix Study Director
study director · Nurix Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: NX-5948

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