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 40 sites in 5 countries.
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
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- 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
- 40 sitesin 5 countries
- Study dates
- 15 Oct 2025to Oct 2030
- Phase
- Phase 2
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
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- 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
40 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 5 countries
United States27 sites, 27 recruiting
- Recruiting
Texas Oncology - Center South
Austin, Texas, 78705
- 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
Italy4 sites, 4 recruiting
- 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
Ospedale San Raffaele S.r.l.
Milan, 20132
- Recruiting
AUSL della Romagna UO Ematologia
Ravenna, 48121
Poland4 sites, 4 recruiting
- 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
United Kingdom4 sites, 4 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| NX-5948 | Experimental | Not described Receives: Drug: NX-5948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
Overall survival
Time from the start date of study treatment to the date of death from any cause
Measured: Up to approximately 5 years
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
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
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
Pharmacokinetic profile of NX-5948
NX-5948 concentrations in blood samples
Measured: Up to approximately 1 year
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
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.
- First posted28 Oct 2025
- Study start15 Oct 2025
- Primary completionJan 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nurix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nurix Study Director, Study director, Nurix Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221500
- Sponsor's protocol ID
- NX-5948-201
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No