Clareo Health | 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 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)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
