NX-5948: Administered orally once daily as a capsule
venetoclax: Administered orally once daily as a tablet per prescribing information
rituximab: Administered as an intravenous (IV) infusion per prescribing information
obinutuzumab: Administered as an IV infusion per prescribing information
Study summary
The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate organ and bone marrow function
* Measurable disease by computed tomography (CT) per iwCLL
* For R/R CLL/SLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi)
* For 1L CLL/SLL, confirmed previously untreated CLL/SLL with a clinical indication for systemic treatment that meets iwCLL criteria
* Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate
Key Exclusion Criteria:
* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment
* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment
* Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation
* Use of systemic corticosteroids (\>20 mg/day prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast
* Previously treated with a BTK degrader
* Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment
* Known central nervous system (CNS) lymphoma or leukemia
* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment
* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment
Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
Primary outcome measure(s)
Number of participants with treatment-emergent adverse events — Up to approximately 7 years
Trial sites (6)
Facility
City
Region
Status
Rocky Mountain Cancer Centers
Aurora
Colorado
Recruiting
University of Miami
Coral Gables
Florida
Not Yet Recruiting
Oncology Associates of Oregon
Eugene
Oregon
Recruiting
UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania
Not Yet Recruiting
SCRI Oncology Partners
Nashville
Tennessee
Recruiting
Texas Oncology - Northeast
Tyler
Texas
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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