Clinical Trial

Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.

Active, Not Recruiting Phase 1
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Summary
This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-04-05; most recent amendment 2026-01-16.
Status change: Recruiting → Active, Not Recruiting 2026-01-16
Status change: Not Yet Recruiting → Recruiting 2024-06-07
Trial Details
NCT Number NCT06359002
Lead Sponsor Byondis B.V.
Conditions Relapsed / Refractory AML, Relapsed / Refractory MDS
Enrollment 16 participants
Start Date 2024-06-25
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-20