RecruitingPhase 2NCT07221500

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)

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)

Sponsor

Nurix Therapeutics, Inc.

Enrollment

100 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (DAYBreak CLL-201) is testing a new drug called NX-5948 in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding after treatment with two key types of targeted therapies — BTK inhibitors and BCL-2 inhibitors. **You may be eligible if...** - You are 18 or older - You have confirmed CLL or SLL that has relapsed or become resistant to treatment - You have previously been treated with both a BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib) and a BCL-2 inhibitor (e.g., venetoclax) - Your overall health score (ECOG) is 0, 1, or 2 - Your organ function (liver, kidneys, bone marrow) is adequate **You may NOT be eligible if...** - You have suspected prolymphocytic leukemia or Richter's transformation - You have received another investigational drug recently (within 5 half-lives or 14 days) - You have certain other active cancers or serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNX-5948

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

Locations(20)

Colorado Blood Institute

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

University of Iowa

Iowa City, Iowa, 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

Virginia Oncology Associates

Norfolk, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07221500

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