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New Antibody-Drug conjugate takes aim at tough leukemias

NCT ID NCT06359002

Disease control Sponsor: Byondis B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This first-in-human trial tests BYON4413, an antibody-drug conjugate designed to target and kill cancer cells in people with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic neoplasms (MDS). The study involves 16 participants and aims to check safety, how the drug moves through the body, and any early signs of effectiveness. It is a small, early-stage trial, so results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BYON4413 (an antibody-drug conjugate given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat AML or MDS.
What could go wrong
This is a very early, small trial (16 people) focused on safety, so it may not show strong benefit. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Having active central nervous system AML or AML of the APL/M3 subtype; * 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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia hematopoietic and lymphoid system neoplasm myelodysplastic syndrome Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed / refractory MDS Relapsed/refractory AML

Contacts and locations

Locations

  • Het Ziekenhuisnetwerk Antwerpen

    Antwerp, Belgium

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Institut Catala d'Oncologia

    Badalona, Spain

  • UZ Leuven

    Leuven, Belgium

  • Universitair Medisch Centrum Groningen

    Groningen, Netherlands

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