Chronic Lymphocytic Leukemia study: NX-5948
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?
An investigational oral medicine being studied for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. It is designed to degrade the BTK protein, thereby disrupting its activity.
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
- The study aims to see if NX‑5948 can help treat chronic lymphocytic leukemia or small lymphocytic lymphoma that has not responded to earlier treatments.
- Who it's for
- Adults with relapsed or refractory CLL or SLL who have previously received both a BTK inhibitor and a BCL‑2 inhibitor.
- What's involved
- Participants will receive the drug and have regular clinic visits and medical tests to monitor safety and effectiveness.
- Time commitment
- The study could last up to 5 years, with ongoing visits as needed if the disease does not progress.
- 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
- 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
- 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 is enrolling
- Phoenix, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- San Diego, 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
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Fairfield, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
+ 21 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; San Diego, California, United States; Denver, Colorado, United States; Coral Gables, Florida, United States and 35 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.