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.
ClinicalTrials ID:NCT07221500
This study evaluates NX-5948, a BTK degrader, in adults with R/R CLL/SLL post-BTK and BCL-2 inhibitor treatment. It assesses efficacy, safety, and pharmacokinetics. Participants, aged ≥18 with confirmed CLL/SLL, ECOG 0-2, and adequate organ function, receive daily oral NX-5948 in 28-day cycles until disease progression or other discontinuation criteria are met.
Patient Parameters
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Program Overview
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.
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.
Eligibility 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 treatment or in combination
- 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
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Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
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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
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Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation
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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
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Previously treated with a BTK degrader
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Previous chimeric antigen receptor (CAR) T-cell therapy or autologous hematopoietic cell transplant <1 year prior to enrollment
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Colorado Blood Institute | 80218 | Denver | Colorado |
| Florida Cancer Specialists | 34232 | Sarasota | Florida |
| University of Iowa | 52242 | Iowa City | Iowa |
| Maryland Oncology Hematology | 20904 | Silver Spring | Maryland |
| Novant Health Cancer Institute | 27103 | Winston-Salem | North Carolina |
| University of Cincinnati | 45221 | Cincinnati | Ohio |
| Oncology Hematology Care | 45014 | Fairfield | Ohio |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - Center South | 78705 | Austin | Texas |
| Virginia Cancer Specialists, PC | 22031 | Fairfax | Virginia |
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