A Phase 1 interventional study of BYON4413 in Relapsed / Refractory AML and Relapsed / Refractory MDS, sponsored by Byondis B.V.. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Byondis B.V. · Phase 1, Interventional, and Treatment
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.
This trial includes two parts. Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined. Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Byondis B.V. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:
Exclusion Criteria:
Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Escalating dose cohorts of BYON4413 for patients with AML or MDS.
Drug: BYON4413
BYON4413 will be administered by IV infusion.
Incidence of dose-limiting toxicities (dose escalation)
Time frame: 21 days
Composite Complete Remission Rate (expansion)
CR + CRh + CRi according ELN 2022 criteria
Time frame: Up to 24 months
Incidence and severity of adverse events
Time frame: Up to 24 months
Number of patients with dose modifications
Time frame: Up to 24 months
Rate of early death
Time frame: Within 3 treatment cycles
Maximum Plasma Concentration (Cmax) BYON4413
Time frame: Up to 24 months
Time to Cmax (Tmax) BYON4413
Time frame: Up to 24 months
Area under the curve (AUC) BYON4413
Time frame: Up to 24 months
Percentage of patients with confirmed anti-BYON4413 antibodies
Time frame: Up to 24 months
Composite Complete Remission Rate (dose escalation)
CR + CRh + CRi according ELN 2022 criteria
Time frame: Up to 24 months
Percentage of blasts in bone marrow change from baseline
Time frame: Up to 24 months
Percentage of blasts in peripheral blood change from baseline
Time frame: Up to 24 months
Objective response rate
CR + CRh + CRi + MLFS + PR according ELN 2022 criteria
Time frame: Up to 24 months
Duration of response
Time frame: Up to 24 months
Relapse-free survival
Time frame: Up to 24 months
Event-free survival
Time frame: Up to 24 months
Time to response
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Byondis B.V.