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2025-521088-10-00RecruitingPhase 2

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)

A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Aug 2026

Next steps

Brief summary (registry, in English)

To evaluate the efficacy of NX-5948 in adults with R/R CLL/SLL previously exposed to a cBTKi, an ncBTKi and a BCL2i in accordance with the 2018 International Workshop on CLL (iwCLL) guidelines (Hallek 2018)

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
45 (estimated)
First submitted
10 Jun 2025
Start date
23 Oct 2025
Lead sponsor
Nurix Therapeutics Inc.
EU CT number
2025-521088-10-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 45
  • 16 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) came back or did not respond, after earlier treatment with a BTK inhibitor and a BCL-2 inhibitor.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Relapsed or refractory CLL or SLL that meets the 2018 iwCLL criteria. People with SLL must have measurable disease on a CT scan, at least 1 lymph node larger than 1.5 cm in its longest diameter. ECOG performance status of 0 to 2.
Earlier treatment
Must have had a cBTKi, an ncBTKi and a BCL-2i, either in separate lines of treatment or together. Cannot have been treated with a BTK degrader before.

Main reasons for not taking part

  • Known or suspected prolymphocytic leukemia or a more aggressive form, including Richter's transformation
  • Investigational drug or anticancer treatment within 5 half-lives or 14 days (whichever is shorter) before the study drug starts
  • Systemic corticosteroids above 20 mg/day prednisone or equivalent in the 7 days before the study drug
  • Systemic immunosuppressive drugs other than corticosteroids within 60 days before the first dose
  • Earlier treatment with a BTK degrader

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or suspected prolymphocytic leukemia or more aggressive phenotype, including Richter’s transformation, a positron emission tomography (PET) scan should be performed and 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.
  • Palliative limited-field radiotherapy within 7 days of the first dose of study drug except for broad field radiotherapy (≥30% of bone marrow or whole brain radiotherapy) within 28 days of the first dose of study drug.."
  • 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

Who the study is looking for

  • 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 both a cBTKi, an ncBTKi and a BCL-2i either in separate lines of therapy or in combination.
  • Patients with SLL must have measurable disease by computed tomography (CT) per iwCLL. Measurable disease is defined as at least 1 lymph node >1.5 cm in longest diameter and measurable in 2 perpendicular dimensions.
  • Adequate organ and bone marrow function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (16)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
University of DebrecenDebrecenHungaryCompleted
Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare ArrigoAlessandriaItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamoItalyRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBresciaItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldolaItalyRecruiting
ASST Grande Ospedale Metropolitano NiguardaMilanItalyRecruiting
San Raffaele OspedaleMilanoItalyRecruiting
Ospedale Santa Maria delle CrociRavennaItalyRecruiting
Università Cattolica del Sacro CuoreRomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyRecruiting
Pratia Hematologia Sp. Z o. oKatowicePolandRecruiting
Pratia MCM KrakowKrakowPolandRecruiting
Aidport sp z o.o.SkorzewoPolandRecruiting
MTZ Clinical Research powered by PratiaWarsawPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.