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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)

RecruitingPhase 2

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Nurix Therapeutics, Inc. · Participants: 100 · Started: Oct 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07221500

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Phoenix
CaliforniaCity of Hope, Duarte
Cedars-Sinai Medical Center, Los Angeles
Scripps Health, San Diego
ColoradoColorado Blood Institute, Denver
FloridaUniversity of Miami, Coral Gables
Florida Cancer Specialists, Sarasota
IndianaFort Wayne Oncology and Hematology, Fort Wayne
Hematology Oncology of Indiana, Indianapolis
IowaUniversity of Iowa, Iowa City
MarylandMaryland Oncology Hematology, Silver Spring
MichiganKarmanos Cancer Center, Detroit
North CarolinaDuke University, Durham
Novant Health Cancer Institute, Winston-Salem
OhioUniversity of Cincinnati, Cincinnati
The Cleveland Clinic Foundation, Cleveland
The Ohio State University, Columbus
Oncology Hematology Care, Fairfield
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TennesseeSCRI Oncology Partners, Nashville
TexasTexas Oncology - Center South, Austin
UtahUniversity of Utah, Salt Lake City
VirginiaVirginia Cancer Specialists, PC, Fairfax
Oncology & Hematology Associates of Southwest VA, Norfolk
Virginia Oncology Associates, Norfolk
WashingtonFred Hutchinson Cancer Center, Seattle
WisconsinThe Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.