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

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

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.

Conditions4

Interventions4

Locations6 sites

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