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

NCT06359002 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Relapsed / Refractory AML
  • Relapsed / Refractory MDS

Interventions

DRUG

BYON4413

BYON4413 will be administered by IV infusion.

Sponsors & Collaborators

  • Byondis B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-09-30
Completion
2026-02-28

Countries

  • Belgium
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359002 on ClinicalTrials.gov