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Clinical Trials in Italy / NCT07221500
Recruiting Phase 2

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)

NCT07221500 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-10-15
Last updated
2026-09-17

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Investigational drug(s) / intervention(s)

NX-5948 →

NX-5948: Oral dose administered once daily. NX-5948 will be given in continuous 28-day cycles.

Study summary

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. Participation could last up to 5 years, and possibly longer, if the disease does not progress.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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 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 Exclusion Criteria: * 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 Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Phoenix Arizona Recruiting
City of Hope Duarte California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Scripps Health San Diego California Recruiting
Colorado Blood Institute Denver Colorado Recruiting
University of Miami Coral Gables Florida Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Fort Wayne Oncology and Hematology Fort Wayne Indiana Recruiting
Hematology Oncology of Indiana Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
Maryland Oncology Hematology Silver Spring Maryland Recruiting
Karmanos Cancer Center Detroit Michigan Recruiting
Duke University Durham North Carolina Recruiting
Novant Health Cancer Institute Winston-Salem North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Oncology Hematology Care Fairfield Ohio Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Texas Oncology - Center South Austin Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia Recruiting
Oncology & Hematology Associates of Southwest VA Norfolk Virginia Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
The Medical College of Wisconsin Milwaukee Wisconsin Recruiting
CHU de Nantes Nantes France Recruiting
Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo Alessandria Italy Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna Italy Recruiting
Ospedale San Raffaele S.r.l. Milan Italy Recruiting
AUSL della Romagna UO Ematologia Ravenna Italy Recruiting
Pratia Hematologia Sp. z o.o. Katowice Poland Recruiting
Pratia S.A. Krakow Poland Recruiting
Aidport Sp. z o.o. Skorzewo Poland Recruiting
Pratia Warszawa / Pratia MTZ Warsaw Poland Recruiting
Oxford University Hospitals NHS Foundation Trust Headington Oxford Recruiting
The Royal Marsden NHS Foundation Trust London United Kingdom Recruiting
Sarah Cannon Research Institute UK, Limited London United Kingdom Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting

More Nurix Therapeutics, Inc. trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221500 on ClinicalTrials.gov ↗ ← All trials in Italy