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)

Part of paid clinical trials in Duarte, California.

Sponsor
Nurix Therapeutics, Inc.
Study ID
NCT07221500
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Oct 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NX-5948

Primary Outcome Measure

Objective response rate without partial response with lymphocytosis (PR-L) as determined by an Independent Review Committee (IRC) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Colorado Blood InstituteDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
University of IowaIowa CityIowa52242-
Maryland Oncology HematologySilver SpringMaryland20904-
Novant Health Cancer InstituteWinston-SalemNorth Carolina27103-
University of CincinnatiCincinnatiOhio45221-
Oncology Hematology CareFairfieldOhio45014-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology - Center SouthAustinTexas78705-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Oncology & Hematology Associates of Southwest VANorfolkVirginia23502-
Virginia Oncology AssociatesNorfolkVirginia23502-

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