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New treatment option for Chronic Lymphocytic Leukemia (CLL)
Official 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)
ClinicalTrials.gov ID: NCT07221500
What this study is testing
What is NX-5948?
NX-5948 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia (cll).
Also referred to as Bexobrutideg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participants with SLL must have measurable disease by radiographic assessment
You likely can't join 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...
- 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...
See the full eligibility 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 therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a...
- 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
- 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...
- 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 Note: Other...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Denver, Colorado, United States
- Coral Gables, Florida, United States
- Sarasota, Florida, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Silver Spring, Maryland, United States
- Detroit, Michigan, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Fairfield, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
- Nantes, France
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Denver, Colorado, United States; Coral Gables, Florida, United States; Sarasota, Florida, United States; Fort Wayne, Indiana, United States; Indianapolis, Indiana, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.