No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
620 (estimated)
Sponsor
Nurix Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has not responded to previous treatments. Participants will receive either NX-5948 or pirtobrutinib to see which is more effective.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.
I have been treated at least once before for my leukemia or lymphoma.
I have shown that my cancer has progressed after treatment.
I have a good performance status, meaning I can carry out daily activities.
I have stable organ and bone marrow function.
My SLL can be measured by a CT scan.
You may not be able to join if
I have been diagnosed with prolymphocytic leukemia or Richter's transformation.
I have taken any investigational drug or anticancer therapy in the last 14 days.
I am currently taking corticosteroids at a dose of 10 mg/day or more.
I have previously been treated with a BTK degrader or noncovalent BTKi.
I have had a heart attack or unstable heart condition in the last 6 months.
I have experienced any serious blood clotting or bleeding issues in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.
Trial Locations
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Status
Eligibility Criteria
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 tha…
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.
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