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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)
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

RecruitingPhase 2

Sponsor: Nurix Therapeutics, Inc.

Conditions: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

Interventions: NX-5948

Countries: United States, France, Italy, Poland, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (37)
  • Duarte, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • Denver, Colorado, United States
  • Coral Gables, Florida, United States
  • Sarasota, Florida, United States
  • Fort Wayne, Indiana, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Silver Spring, Maryland, United States
  • Detroit, Michigan, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Fairfield, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Salt Lake City, Utah, United States
  • Fairfax, Virginia, United States
  • Norfolk, Virginia, United States
  • Norfolk, Virginia, United States
  • Seattle, Washington, United States
  • Nantes, France
  • Alessandria, Italy
  • Bologna, Italy
  • Milan, Italy
  • Ravenna, Italy
  • + 7 more on CT.gov