Status:
RECRUITING
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)
Lead Sponsor:
Nurix Therapeutics, Inc.
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 and a BCL...
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 differ...
Eligibility Criteria
Inclusion
- Age: ≥ 18 years
- Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for systemic treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Must have received both a BTK inhibitor and a BCL-2 inhibitor
- 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
- Known or suspected prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma or other types of non-Hodgkin's lymphoma 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
- Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation
- 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
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07221500
Start Date
October 15 2025
End Date
October 1 2030
Last Update
December 17 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Nantes
Nantes, France, 44000
2
Pratia Hematologia Sp. z o.o.
Katowice, Poland, 40-519
3
Pratia S.A.
Krakow, Poland, 30-225
4
Aidport Sp. z o.o.
Skorzewo, Poland, 60-185