Clinical trial · Interventional
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
NCT07520006CI-TRIAL-00124598recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NX-5948 | Drug | — | UNRESOLVED |
| obinutuzumab | Drug | Obinutuzumab | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
| venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NX-5948 + venetoclax
- interventionNames
- Drug: NX-5948
- Drug: venetoclax
- type
- EXPERIMENTAL
- label
- NX-5948 + venetoclax + rituximab
- interventionNames
- Drug: NX-5948
- Drug: venetoclax
- Drug: rituximab
- type
- EXPERIMENTAL
- label
- NX-5948 + venetoclax + obinutuzumab
- interventionNames
- Drug: NX-5948
- Drug: venetoclax
- Drug: obinutuzumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.