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

NCT07516093 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NX-5948-3062025-524145-27-002025
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

B-cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); Degrader; B-cell malignancy; BTKi; Bexobrutideg; Pirtobrutinib

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to approximately 2.5 years

Secondary Outcomes (11)

• Overall survival

  Up to approximately 7 years

• PFS as assessed by the investigator

  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

  Up to approximately 3.5 years

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

  Up to approximately 3.5 years

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

  Up to approximately 3.5 years

Study Arms (2)

Arm A: NX-5948

EXPERIMENTAL

Drug: NX-5948

Arm B: Pirtobrutinib

EXPERIMENTAL

Drug: Pirtobrutinib

Interventions

NX-5948 DRUG

Administered orally once daily

Also known as: Bexobrutideg

Arm A: NX-5948

Pirtobrutinib DRUG

Administered orally once daily per prescribing information

Also known as: JAYPIRCA

Arm B: Pirtobrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (6)

Central Georgia Cancer Care

Macon, Georgia, 31210, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

RECRUITING

Hematology Oncology of Indiana

Indianapolis, Indiana, 46260, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - West Texas

Midland, Texas, 79124, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22201, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

pirtobrutinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Nurix Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Additional Site Contact Information

CONTACT

415-417-3418; clinicaltrials@nurixtx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): August 1, 2033
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)