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NCT Number: NCT07516093

Study of NX-5948 Versus Pirtobrutinib in R/R CLL/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.

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Key information

Conditions

B-cell Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central Georgia Cancer Care, Macon, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NX-5948

Drug

Administered orally once daily

Other names: Bexobrutideg

Pirtobrutinib

Drug

Administered orally once daily per prescribing information

Other names: JAYPIRCA

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Overall survival

    Time frame: Up to approximately 7 years

    Time from randomization to death from any cause

  2. PFS as assessed by the investigator

    Time frame: Up to approximately 3.5 years

    Time from randomization to disease progression or death due to any cause, whichever is earlier

  3. 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

    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

  4. Duration of response with and without PR-L as assessed by IRC and investigator

    Time frame: Up to approximately 3.5 years

    Time from the date of the first response to documented disease progression or death due to any cause, whichever is earlier

  5. Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator

    Time frame: Up to approximately 3.5 years

    Time from randomization to the date of next anti-CLL/SLL treatment

  6. 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

    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

  7. Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)

    Time frame: Baseline and up to approximately 3.5 years

    Percentage of participants with a clinically meaningful change from baseline using the EQ-5D-5L questionnaire to assess health outcomes

  8. Number of participants with treatment-emergent adverse events

    Time frame: Up to approximately 3.5 years

  9. Pharmacokinetic profile of NX-5948

    Time frame: Up to Cycle 13 Day 1 (each cycle is 28 days)

    NX-5948 concentrations in blood samples

  10. Number of participants with clinically significant changes from baseline in laboratory parameters

    Time frame: Up to approximately 3.5 years

    Laboratory parameters may include hematology, clinical chemistry, and urinalysis

  11. Number of participants with clinically significant changes from baseline in vital signs

    Time frame: Up to approximately 3.5 years

    Vital signs include blood pressure, heart and respiratory rates, pulse oximetry, and temperature

Study contacts

Contact information is provided by the study sponsor or research team.

Additional Site Contact Information

CONTACT

[email protected]

415-417-3418

Sponsors and collaborators

Lead sponsor

Nurix Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Apr 7, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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