Clinical Trial: NCT05737628
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Byondis B.V. |
| Information Provided By: | Byondis B.V. |
| Last Update Posted: | 2026-01-16 |
Study Overview
Brief Summary
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
Official Title
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination With Rituximab to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Relapsed/Refractory CD20 Positive B-cell Non-Hodgkin's Lymphoma (NHL)
Conditions
Lymphoma
Intervention / Treatment
- Drug: BYON4228 + Rituximab
Other Study ID Numbers
- BYON4228.001
Start Date (Actual)
2024-03-04
Primary Completion Date (Estimated)
2026-02
Study Completion Date (Estimated)
2026-05
Enrollment (Actual)
17
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Byondis B.V. |
| Information Provided By: | Byondis B.V. |
| Last Update Posted: | 2026-01-16 |
Study Overview
Brief Summary
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
Official Title
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination With Rituximab to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Relapsed/Refractory CD20 Positive B-cell Non-Hodgkin's Lymphoma (NHL)
Conditions
Lymphoma
Intervention / Treatment
- Drug: BYON4228 + Rituximab
Other Study ID Numbers
- BYON4228.001
Start Date (Actual)
2024-03-04
Primary Completion Date (Estimated)
2026-02
Study Completion Date (Estimated)
2026-05
Enrollment (Actual)
17
Study Type
Interventional
Phase
Phase 1