Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NX-5948, venetoclax, rituximab, obinutuzumab.
- Who it may be relevant to
- Registry conditions: B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Detailed description
Bexobrutideg is an investigational drug designed to target a protein called Bruton tyrosine kinase (BTK), which helps cancer cells grow in certain blood cancers like CLL and SLL. Bexobrutideg is a protein degrader, which means it finds and destroys the BTK in the cell. Venetoclax, rituximab, and obinutuzumab are approved medications that are used to treat CLL/SLL.
The study will look at:
* How safe bexobrutideg is for patients with CLL or SLL when taken with these other treatments * The effects of bexobrutideg in the body when taken with these other treatments * How well bexobrutideg treats CLL or SLL when taken with these other treatments
Interventions
- Drug NX-5948
Administered orally once daily as a capsule - Drug venetoclax
Administered orally once daily as a tablet per prescribing information - Drug rituximab
Administered as an intravenous (IV) infusion per prescribing information - Drug obinutuzumab
Administered as an IV infusion per prescribing information
Primary outcome measures
- Number of participants with treatment-emergent adverse events [Time frame: Up to approximately 7 years]
Secondary outcome measures (10)
- Objective response rate as determined by investigator [Time frame: Up to approximately 7 years]
- Duration of response as determined by investigator [Time frame: Up to approximately 7 years]
- Progression-free survival as determined by investigator [Time frame: Up to approximately 7 years]
- Complete response rate as determined by investigator [Time frame: Up to approximately 7 years]
- Time to response as determined by investigator [Time frame: Up to approximately 7 years]
- Overall survival [Time frame: Up to approximately 7 years]
- Pharmacokinetic profile of NX-5948 [Time frame: Up to approximately 1 year]
- Pharmacokinetic profile of venetoclax [Time frame: Up to approximately 1 year]
- Change from baseline in Global Health Status/Quality of Life on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Baseline and up to approximately 27 months]
- Change from baseline in European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L) [Time frame: Baseline and up to approximately 27 months]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07520006 · NX-5948-203