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A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a Bcell Lymphoma-2 Inhibitor (BCL-2i) (DAYBreak CLL-201)
EU CTIS ID: 2025-521088-10-00
What this study is testing
To evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, a ncBTKi, and a BCL-2i in accordance with iwCLL guidelines (Hallek 2018)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: ≥ 18 years
- Confirmed diagnosis of CLL/SLL that meets iwCLL criteria diagnosis and systemic treatment (Hallek 2018)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Prior exposure to a cBTKI, a ncBTKi, and a BCL2i either in separate lines of treatment or in combination
- Measurable disease by computed tomography (CT) per iwCLL
- Adequate organ and bone marrow function
You likely can't join if
- Known or suspected prolymphocytic leukemia or Richter’s transformation at any time preceding enrolment. Note: In cases of clinical suspicion of Richter's Transformation, the treating physician may determine if histopathological evaluation should be performed and results reviewed by the treating physician to rule out transformation prior to enrollment.
- Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug.
- Radiotherapy within 2 weeks of the first dose of study treatment
- Use of systemic corticosteroids >20 mg/day prednisone or equivalent within the 7 days prior to initiation of study drug excepting those used as prophylaxis for radio diagnostic contrast
- Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug
- Previously treated with a BTK degrader
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- United States
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; United States; Turkey. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.