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Recruiting Phase 3

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

NCT07516093 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-08-03
Last updated
2026-08-31

Condition(s) studied

B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

NX-5948 →Pirtobrutinib →

NX-5948: Administered orally once daily

Pirtobrutinib: Administered orally once daily per prescribing information

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) — 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 — 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

Trial sites (6)

FacilityCityRegionStatus
Central Georgia Cancer Care Macon Georgia Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
Hematology Oncology of Indiana Indianapolis Indiana Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Texas Oncology - West Texas Midland Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07516093 on ClinicalTrials.gov ↗ ← All trials in the USA