NCT06359002Active, not recruitingPhase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.
A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 26 Mar 2024
- Start date
- 25 Jun 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Byondis B.V.
- NCT number
- NCT06359002
- EU CT number
- 2023-507781-13-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 25 Jun 2024 to the primary completion date, 30 Sept 2025
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having been treated with any CD123-targeting therapies;
- Having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start Cycle 1 Day 1;
- Having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to CTCAE Grade ≤ 1;
Other illness
- History of keratitis;
- History of specified lung or renal disease;
- Having clinically significant cardiovascular disease;
- Known infection of Hepatitis B, C or E.
- Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
Other
- Having active central nervous system AML or AML of the APL/M3 subtype;
Who the study is looking for
- Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:
- R/R AML (WHO 2022) OR
- MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
- Adequate baseline organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Ziekenhuisnetwerk Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.