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)
Purpose
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.
Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- 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 - 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 or autologous hematopoietic cell transplant <1 year 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single Group
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NX-5948 |
|
Recruiting Locations
Denver 5419384, Colorado 5417618 80218
Nashville 4644585, Tennessee 4662168 37203
Austin 4671654, Texas 4736286 78705
More Details
- Status
- Recruiting
- Sponsor
- Nurix Therapeutics, Inc.
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.