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RECRUITING
NCT07221500
PHASE2

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)

Sponsor: Nurix Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-10-15

Completion Date

2030-10

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

NX-5948

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

Locations (18)

Colorado Blood Institute

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Novant Health Cancer Institute

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oncology Hematology Care

Fairfield, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Center South

Austin, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

CHU de Nantes

Nantes, France

AUSL della Romagna UO Ematologia

Ravenna, Italy

Pratia Hematologia Sp. z o.o.

Katowice, Poland

Pratia S.A.

Krakow, Poland

Aidport Sp. z o.o.

Skorzewo, Poland

Pratia Warszawa / Pratia MTZ

Warsaw, Poland

Oxford University Hospitals NHS Foundation Trust

Headington, Oxford, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom