BYON4413: BYON4413 will be administered by IV infusion.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of dose-limiting toxicities (dose escalation) — 21 days
Composite Complete Remission Rate (expansion) — Up to 24 months CR + CRh + CRi according ELN 2022 criteria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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