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

A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

Phase 2 Interventional Nurix Therapeutics, Inc. · NCT07221500

NX-5948, an oral BTK degrader, will be tried to see if it helps adults with relapsed or refractory CLL or SLL who have already been treated with both BTK and BCL-2 inhibitors.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorNurix Therapeutics, Inc. Industry-sponsored
Drugs / interventionschimeric antigen receptor, radiation, prednisone
Locations20 sites (Denver, Colorado and 19 other locations)
Trial IDNCT07221500 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with measurable relapsed/refractory CLL or SLL, ECOG 0–2, adequate organ and bone marrow function, and prior treatment with both covalent and non-covalent BTK inhibitors plus a BCL-2 inhibitor are the intended participants.

Not a fit: Patients with Richter's transformation or prolymphocytic leukemia, those who have not received the required prior BTK and BCL-2 inhibitor treatments, or those with inadequate organ function are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, NX-5948 could provide a new option that overcomes BTK-related resistance and produces meaningful responses for patients with limited treatment choices.

How similar studies have performed: BTK degradation is a relatively new approach: traditional BTK inhibitors have established benefit but resistance is common, and early-phase data on BTK degraders show preliminary activity but remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 treatment or in combination
* 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
* 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 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 autologous hematopoietic cell transplant \<1 year 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 this trial is running

Denver, Colorado and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaBTK DegraderBTK InhibitorBCL-2 InhibitorB-cell MalignancyLymphomaBruton's Tyrosine Kinase
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.