What this study is
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).
What's being tested
- NX-5948
Intervention · DRUG
Administered orally once daily as a capsule
- venetoclax
Intervention · DRUG
Administered orally once daily as a tablet per prescribing information
- rituximab
Intervention · DRUG
Administered as an intravenous (IV) infusion per prescribing information
- obinutuzumab
Intervention · DRUG
Administered as an IV infusion per prescribing information
Study details
- Official title
- An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
- Sponsor
- Nurix Therapeutics, Inc.
- Conditions
- B-cell Lymphoma · Chronic Lymphocytic Leukemia · Small Lymphocytic Lymphoma
- Enrolling
- 150 people
- Starts
- 2026-09-30
- Est. completion
- 2033-05
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openRocky Mountain Cancer Centers
Aurora, Colorado, United States
RecruitingUniversity of Miami
Coral Gables, Florida, United States
Not yet recruitingUniversity of Kansas Cancer Center
Kansas City, Kansas, United States
Not yet recruitingComprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Not yet recruitingNew Jersey Cancer Care
Belleville, New Jersey, United States
Not yet recruitingOncology Associates of Oregon
Eugene, Oregon, United States
RecruitingUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RecruitingSCRI Oncology Partners
Nashville, Tennessee, United States
RecruitingTexas Oncology - Northeast
Tyler, Texas, United States
Recruiting
Study team
Sponsor
Nurix Therapeutics, Inc.
Study ID NX-5948-203
Study director
Study Director
Nurix Therapeutics, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.