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

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 phase 3 trial compares NX-5948, a BTK degrader, to pirtobrutinib in patients with relapsed or refractory CLL/SLL who previously progressed on covalent BTK inhibitors. Eligible participants have ECOG 0-2 and adequate organ function, with measurable disease by iwCLL 2018 criteria. The study excludes those with certain BTK-degrader exposure, recent systemic steroids, or specific disease transformations, and requires prior BTK inhibitor therapy. Primary endpoints likely include efficacy and safety to determine if NX-5948 can improve outcomes compared with an active BTK inhibitor. Investigational sites are located in Georgia and Indiana.

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
* Confirmed diagnosis of CLL/SLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment
* Received at least 1 prior line of therapy for CLL/SLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi
* Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL

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
* Ongoing systemic corticosteroids ≥10 mg/day prednisone or equivalent
* Previously treated with a BTK degrader or a noncovalent BTKi
* 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

• Central Georgia Cancer Care
  Macon, Georgia, United States Recruiting
• Fort Wayne Medical Oncology and Hematology
  Fort Wayne, Indiana, United States Recruiting
• Hematology Oncology of Indiana
  Indianapolis, Indiana, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Texas Oncology - West Texas
  Midland, Texas, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States 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 plus other medicines for B-cell cancers

  This trial tests NX-5948 in combination with venetoclax, with or without anti-CD20 antibodies, for adults with CLL/SLL or B-cell lymphoma that has returned or worsened or is newly diagnosed but needing treatment.

  Recruiting at 5 sites Phase 1/2 Nurix Therapeutics, Inc. · Aurora, Colorado and 8 other locations · NCT07520006

• Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL

  This trial tests whether BGB-16673 works better and is as safe as pirtobrutinib for adults whose CLL or SLL has come back or not responded after prior covalent BTK inhibitor treatment.

  Recruiting at 217 sites Phase 3 BeOne Medicines · Birmingham, Alabama and 216 other locations · NCT06973187

• Evaluating Pirtobrutinib for patients with relapsed or refractory CLL/SLL

  This study is testing a new medication called Pirtobrutinib to see if it helps people with relapsed or hard-to-treat chronic lymphocytic leukemia or small lymphocytic lymphoma feel better after they’ve already tried other treatments.

  Recruiting at 125 sites Phase 2 Eli Lilly and Company · Chandler, Arizona and 128 other locations · NCT06588478

• Combining pirtobrutinib and venetoclax for treating resistant CLL or SLL

  This study is testing if combining two drugs, pirtobrutinib and venetoclax, can help people with chronic lymphocytic leukemia or small lymphocytic lymphoma that hasn’t responded to previous treatments.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT06466122

• Fixed-duration treatment for chronic lymphocytic leukemia with pirtobrutinib and obinutuzumab

  This study is testing a year-long treatment combining two medications, pirtobrutinib and obinutuzumab, to see if it helps people with chronic lymphocytic leukemia feel better.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · Scarborough, Maine and 3 other locations · NCT06333262

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

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.