NX-5948 treatment for adults with CLL or SLL after prior BTK and BCL-2 inhibitor therapy

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 2, open-label study gives oral NX-5948 to adults with relapsed or refractory CLL/SLL who previously received both covalent and non-covalent BTK inhibitors plus a BCL-2 inhibitor. Participants remain on NX-5948 until disease progression or unacceptable side effects, with regular tumor assessments and safety monitoring. The study records response rates, duration of response, safety/tolerability, and drug levels in the blood over time. Participation may last up to five years with ongoing follow-up after treatment stops if disease has not progressed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: ≥ 18 years
* Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen
* Participants with SLL must have measurable disease by radiographic assessment
* Adequate organ and bone marrow function
* Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate

Exclusion Criteria:

* Known or suspected prolymphocytic leukemia or Richter's transformation before entering study
* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug

  * Antibody therapy must stop at least 4 weeks before the first dose of study drug
  * No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study
* Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug
* Use of systemic corticosteroids \>20 mg/day prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast
* Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug
* Previously treated with a BTK degrader
* Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment
* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug

Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Where it's running

• Banner MD Anderson Cancer Center
  Phoenix, Arizona, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Scripps Health
  San Diego, California, United States Recruiting
• Colorado Blood Institute
  Denver, Colorado, United States Recruiting
• University of Miami
  Coral Gables, Florida, 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.

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

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• Immune profiling during first-line pirtobrutinib treatment for CLL/SLL

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  Recruiting Early Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07428707

• Quality of life and symptom changes over two years in adults with CLL or SLL starting targeted therapy

  This study will see how quality of life, fatigue, and symptoms change over two years for adults with CLL or SLL who start treatment with a BTK inhibitor versus a BCL2 inhibitor.

  Recruiting H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07030400

• Acalabrutinib and Venetoclax for relapsed CLL/SLL after initial BTKi+BCL2i response

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  Recruiting at 16 sites Phase 2 AstraZeneca · Boston, Massachusetts and 46 other locations · NCT07024706

• Long-term safety of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL

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  Recruiting Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Milwaukee, Wisconsin · NCT06788639

• Combination of zanubrutinib and venetoclax for treating chronic lymphocytic leukemia

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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.