B-cell LymphomaPhase 1/2NCT07520006
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
A Phase 1/2 study testing NX-5948, venetoclax and rituximab 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 NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 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, venetoclax and rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Sep 2026to May 2033
- Phase
- Phase 1/2
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
- Measurable disease by computed tomography (CT) per iwCLL
- For R/R CLL/SLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi)
- For 1L CLL/SLL, confirmed previously untreated CLL/SLL with a clinical indication for systemic treatment that meets iwCLL criteria
- Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate
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
- 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 prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast
- Previously treated with a BTK degrader
- Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment
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- Known central nervous system (CNS) lymphoma or leukemia
- 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
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
- Not yet recruiting
University of Miami
Coral Gables, Florida, 33146
- Recruiting
Oncology Associates of Oregon
Eugene, Oregon, 97401
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Texas Oncology - Northeast
Tyler, Texas, 75702
About this study
Official title: An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Read the detailed description
Bexobrutideg is an investigational drug designed to target a protein called Bruton tyrosine kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. Bexobrutideg is a protein degrader, which means it finds and destroys the BTK in the cell. Venetoclax, rituximab, and obinutuzumab are approved medications that are used to treat CLL/SLL.
The study will look at:
- How safe bexobrutideg is for patients with CLL or SLL when taken with these other treatments
- The effects of bexobrutideg in the body when taken with these other treatments
- How well bexobrutideg treats CLL or SLL when taken with these other treatments
- Being tested
- NX-5948, venetoclax, rituximab, obinutuzumab
- Keywords
- Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Degrader, B-cell malignancy, BTKi, Bexobrutideg, Venetoclax, Obinutuzumab, Rituximab
- 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 as a capsule
venetoclaxDrug
Administered orally once daily as a tablet per prescribing information
rituximabDrug
Administered as an intravenous (IV) infusion per prescribing information
obinutuzumabDrug
Administered as an IV infusion per prescribing information
| Study group | Role | What they receive |
|---|---|---|
| NX-5948 + venetoclax | Experimental | Not described Receives: Drug: NX-5948; Drug: venetoclax |
| NX-5948 + venetoclax + rituximab | Experimental | Not described Receives: Drug: NX-5948; Drug: venetoclax; Drug: rituximab |
| NX-5948 + venetoclax + obinutuzumab | Experimental | Not described Receives: Drug: NX-5948; Drug: venetoclax; Drug: obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Measured: Up to approximately 7 years
Secondary outcomes (10)
Objective response rate as determined by investigator
The percentage of participants with response as determined according to 2018 iwCLL guidelines; response includes complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), PR with lymphocytosis (PR-L), and nodular PR
Measured: Up to approximately 7 years
Duration of response as determined by investigator
Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier
Measured: Up to approximately 7 years
Progression-free survival as determined by investigator
Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier
Measured: Up to approximately 7 years
Complete response rate as determined by investigator
The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines; includes CR + CRi for participants with CLL.
Measured: Up to approximately 7 years
Time to response as determined by investigator
Time from the start date of study treatment to the date of the first assessment of a response
Measured: Up to approximately 7 years
Overall survival
Time from the start date of study treatment to the date of death from any cause
Measured: Up to approximately 7 years
Pharmacokinetic profile of NX-5948
NX-5948 concentrations in blood samples
Measured: Up to approximately 1 year
Pharmacokinetic profile of venetoclax
Venetoclax concentrations in blood samples
Measured: Up to approximately 1 year
Change from baseline in Global Health Status/Quality of Life on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
Percentage of participants with a clinically meaningful change from baseline using the EORTC QLQ-C30 questionnaire to assess the overall quality of life
Measured: Baseline and up to approximately 27 months
Change from baseline in European Quality of Life 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 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Sep 2026
- Primary completionMay 2033 (estimated)
- Study completionMay 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT07520006
- Sponsor's protocol ID
- NX-5948-203
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No