NX-5948 plus other medicines for B-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional study combining NX-5948 (a protein degrader targeting BTK) with venetoclax, and possibly rituximab or obinutuzumab, in adults with CLL/SLL or related B-cell non-Hodgkin lymphomas. The study has phase 1 and phase 2 components to evaluate safety, how the drug behaves in the body, and effectiveness when used with these therapies. Eligible participants include those with relapsed/refractory disease after BTKi therapy or those with 1L disease requiring systemic treatment. Key inclusion criteria emphasize measurable disease, adequate organ function, and consent, while major exclusions include certain leukemias, recent anticancer therapy, or recent radiotherapy. The trial is sponsored by Nurix Therapeutics with sites in Colorado, Florida, and Kansas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rocky Mountain Cancer Centers
  Aurora, Colorado, United States Recruiting
• Oncology Associates of Oregon
  Eugene, Oregon, United States Recruiting
• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Texas Oncology - Northeast
  Tyler, Texas, United States Recruiting
• University of Miami
  Coral Gables, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Additional Site Contact Information
• Email: clinicaltrials@nurixtx.com
• Phone: 415-417-3418

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NX-5948 vs Pirtobrutinib in R/R CLL/SLL

  This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.

  Recruiting at 6 sites Phase 3 Nurix Therapeutics, Inc. · Macon, Georgia and 5 other locations · NCT07516093

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• Venetoclax plus obinutuzumab followed by epcoritamab for untreated CLL/SLL

  This trial tests whether giving venetoclax and obinutuzumab followed by epcoritamab can produce deep remissions in people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting at 4 sites Phase 2 City of Hope Medical Center · Duarte, California and 6 other locations · NCT07218510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.