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Recruiting Phase 1/2

Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

NCT07520006 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2026-09-30
Last updated
2026-10-22

Condition(s) studied

B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

NX-5948 →venetoclax →rituximab →obinutuzumab →

NX-5948: Administered orally once daily as a capsule

venetoclax: Administered orally once daily as a tablet per prescribing information

rituximab: Administered as an intravenous (IV) infusion per prescribing information

obinutuzumab: Administered as an IV infusion per prescribing information

Study 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).

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 * 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 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 * 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 * 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.

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events — Up to approximately 7 years

Trial sites (6)

FacilityCityRegionStatus
Rocky Mountain Cancer Centers Aurora Colorado Recruiting
University of Miami Coral Gables Florida Not Yet Recruiting
Oncology Associates of Oregon Eugene Oregon Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Texas Oncology - Northeast Tyler Texas 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 NCT07520006 on ClinicalTrials.gov ↗ ← All trials in the USA