B-cell LymphomaPhase 3NCT07516093
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL
A Phase 3 study testing NX-5948 and Pirtobrutinib in people with B-cell Lymphoma and Chronic Lymphocytic Leukemia, run by Nurix Therapeutics, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- NX-5948 and Pirtobrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Aug 2026to Aug 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22201
- Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
- Recruiting
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260
- Recruiting
Central Georgia Cancer Care
Macon, Georgia, 31210
- Recruiting
Texas Oncology - West Texas
Midland, Texas, 79124
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
About this study
Official title: A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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.
- Being tested
- NX-5948, Pirtobrutinib
- Keywords
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Degrader, B-cell malignancy, BTKi, Bexobrutideg, Pirtobrutinib
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-5948Drug
Also called Bexobrutideg
Administered orally once daily
PirtobrutinibDrug
Also called JAYPIRCA
Administered orally once daily per prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Arm A: NX-5948 | Experimental | Not described Receives: Drug: NX-5948 |
| Arm B: Pirtobrutinib | Experimental | Not described Receives: Drug: Pirtobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Measured: Up to approximately 3.5 years
Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
Measured: Up to approximately 2.5 years
Secondary outcomes (11)
Overall survival
Time from randomization to death from any cause
Measured: Up to approximately 7 years
PFS as assessed by the investigator
Time from randomization to disease progression or death due to any cause, whichever is earlier
Measured: Up to approximately 3.5 years
Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR) or nodular PR, or PR-L (for ORR with PR-L), as assessed per 2018 International Workshop on CLL (iwCLL) guidelines
Measured: Up to approximately 3.5 years
Duration of response with and without PR-L as assessed by IRC and investigator
Time from the date of the first response to documented disease progression or death due to any cause, whichever is earlier
Measured: Up to approximately 3.5 years
Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator
Time from randomization to the date of next anti-CLL/SLL treatment
Measured: Up to approximately 3.5 years
Change from baseline in global health status/quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire C30 with CLL module (EORTC QLQ-C30-CLL17)
Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30-CLL17 questionnaire to assess global health and overall quality of life
Measured: Baseline and up to approximately 3.5 years
Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes
Measured: Baseline and up to approximately 3.5 years
Number of participants with treatment-emergent adverse events
Measured: Up to approximately 3.5 years
Pharmacokinetic profile of NX-5948
NX-5948 concentrations in blood samples
Measured: Up to Cycle 13 Day 1 (each cycle is 28 days)
Number of participants with clinically significant changes from baseline in laboratory parameters
Laboratory parameters may include hematology, clinical chemistry, and urinalysis
Measured: Up to approximately 3.5 years
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature
Measured: Up to approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start3 Aug 2026
- Primary completionOct 2029 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nurix Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516093
- Sponsor's protocol ID
- NX-5948-306
- Other IDs
- 2025-524145-27-00, 2025
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- ClinicalTrials.gov ID
- NCT07516093
- Acronym / sponsor ID
- NX-5948-306
- Keywords
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Degrader, B-cell malignancy, BTKi, Bexobrutideg, Pirtobrutinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Nurix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: NX-5948 | Experimental | Drug: NX-5948 |
| Arm B: Pirtobrutinib | Experimental | Drug: Pirtobrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NX-5948Also: BexobrutidegAdministered orally once daily | Drug | Arm A: NX-5948 |
| PirtobrutinibAlso: JAYPIRCAAdministered orally once daily per prescribing information | Drug | Arm B: Pirtobrutinib |
Primary outcome
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Time frame: Up to approximately 3.5 years
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC
Time frame: Up to approximately 2.5 years
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
11 secondary outcomes
Overall survival
Time frame: Up to approximately 7 years
PFS as assessed by the investigator
Time frame: Up to approximately 3.5 years
Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator
Time frame: Up to approximately 3.5 years
Duration of response with and without PR-L as assessed by IRC and investigator
Time frame: Up to approximately 3.5 years
Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator
Time frame: Up to approximately 3.5 years
Change from baseline in global health status/quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire C30 with CLL module (EORTC QLQ-C30-CLL17)
Time frame: Baseline and up to approximately 3.5 years
Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)
Time frame: Baseline and up to approximately 3.5 years
Number of participants with treatment-emergent adverse events
Time frame: Up to approximately 3.5 years
Pharmacokinetic profile of NX-5948
Time frame: Up to Cycle 13 Day 1 (each cycle is 28 days)
Number of participants with clinically significant changes from baseline in laboratory parameters
Time frame: Up to approximately 3.5 years
Number of participants with clinically significant changes from baseline in vital signs
Time frame: Up to approximately 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Nurix Therapeutics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NX-5948 and Pirtobrutinib in people with B-cell Lymphoma and Chronic Lymphocytic Leukemia, run by Nurix Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Additional Site Contact Information (415-417-3418, clinicaltrials@nurixtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) (time frame: Up to approximately 3.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.