Actively Recruiting
A Study of NX-5948 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated With a BTK Inhibitor and a BCL-2 Inhibitor
Led by Nurix Therapeutics, Inc. · Updated on 2026-05-28
100
Participants Needed
24
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug NX-5948 in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with both a Bruton's Tyrosine Kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor. This phase 2, open-label study aims to determine how well NX-5948 works, assess its safety, and understand how it behaves in the body over time. NX-5948 is a BTK degrader designed to destroy the BTK protein, differing from BTK inhibitors that only block part of its function. The study could last up to five years or longer if the disease does not progress. All participants will receive NX-5948 orally once daily in continuous 28-day cycles until their cancer worsens or other reasons require stopping the treatment. During treatment, participants will have regular health and cancer check-ups. If a participant stops taking NX-5948 without disease progression, cancer monitoring will continue until progression occurs. This approach allows researchers to observe the drug's effects over time while ensuring ongoing safety assessments. Participants will be involved in regular assessments including cancer evaluations and health monitoring throughout the study duration. Researchers will review the objective response rate as the primary outcome, along with other measures like progression-free survival, duration of response, overall survival, adverse events, and changes in quality of life. Blood samples will be taken to study the drug's pharmacokinetics. Safety monitoring will continue for up to three years, while efficacy and quality of life assessments may extend up to five years or more, ensuring comprehensive data collection over the long term.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed relapsed or refractory CLL or SLL meeting iwCLL criteria for diagnosis and systemic treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Prior treatment with a covalent BTK inhibitor, a non-covalent BTK inhibitor, and a BCL-2 inhibitor either separately or combined
- Measurable disease by radiographic assessment for participants with SLL
- Adequate organ and bone marrow function
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Known or suspected prolymphocytic leukemia or Richter's transformation before study entry
- Use of investigational agent or anticancer therapy within 5 half-lives or 14 days before starting study drug
- Antibody therapy must have stopped at least 4 weeks before first dose of study drug
- No other systemic anticancer therapy allowed during the study except certain hormonal therapies
- Palliative limited-field radiotherapy within 7 days or broad field radiotherapy within 28 days before starting study drug
- Use of systemic corticosteroids over 20 mg/day prednisone or equivalent within 7 days before study drug start (except premedication for contrast)
- Use of systemic immunosuppressive drugs other than corticosteroids within 60 days before study drug start
- Previous treatment with a BTK degrader
- CAR T-cell therapy or hematopoietic cell transplant within 90 days before enrollment
- Thromboembolic events, stroke, or intracranial hemorrhage within 6 months before starting study drug
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants take oral NX-5948 once daily in continuous 28-day cycles to treat their condition until their cancer worsens or another reason stops treatment. Regular cancer and health check-ups occur during this time.
Regular visits for treatment and health assessments
Duration - Up to approximately 5 years
If participants stop taking NX-5948 without cancer progression, they continue having cancer check-ups until their cancer worsens.
Periodic visits for cancer monitoring
Trial Site Locations
Total: 24 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Colorado Blood Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Maryland Oncology Hematology
Silver Spring, Maryland, United States, 20904
Actively Recruiting
6
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
7
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
8
Oncology Hematology Care
Fairfield, Ohio, United States, 45014
Actively Recruiting
9
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Texas Oncology - Center South
Austin, Texas, United States, 78705
Actively Recruiting
11
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Oncology & Hematology Associates of Southwest VA
Norfolk, Virginia, United States, 23502
Actively Recruiting
13
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
14
CHU de Nantes
Nantes, France, 44000
Actively Recruiting
15
Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
Actively Recruiting
16
Ospedale San Raffaele S.r.l.
Milan, Italy, 20132
Actively Recruiting
17
AUSL della Romagna UO Ematologia
Ravenna, Italy, 48121
Actively Recruiting
18
Pratia Hematologia Sp. z o.o.
Katowice, Poland, 40-519
Actively Recruiting
19
Pratia S.A.
Krakow, Poland, 30-225
Actively Recruiting
20
Aidport Sp. z o.o.
Skorzewo, Poland, 60-185
Actively Recruiting
21
Pratia Warszawa / Pratia MTZ
Warsaw, Poland, 02-172
Actively Recruiting
22
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, United Kingdom, OX3 9D
Actively Recruiting
23
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
24
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
A
Additional Site Contact Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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