Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
About this study
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).
- Condition
- B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Tested
- NX-5948, venetoclax, rituximab, obinutuzumab
- Sponsor
- Nurix Therapeutics, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- 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
Exclusion 10
- 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.
Where
6 sites, 6 recruiting
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Miami
Coral Gables, Florida, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Texas Oncology - Northeast
Tyler, Texas, United States
Contact
-
Additional Site Contact Information
415-417-3418 clinicaltrials@nurixtx.com
Potential match only. Final eligibility is determined by the study team.