Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0SRZCK |
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| Antibody Name | A humanized anti-CD123 IgG1 mAb |
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| Antigen Name | CD123 |
Antigen Info | ||||
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
BYON-4413 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients have R/R AML or high-blast MDS post-HMA failure (≥3 cycles) with ECOG 0-2; exclusions comprise prior CD123 therapy, recent HSCT (<100 days), unresolved toxicities (>CTCAE Gr1), APL/CNS involvement, active hepatitis, or significant cardiovascular/pulmonary/ocular comorbidities.
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| Administration Dosage |
BYON4413 will be administered by IV infusion.
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| Related Clinical Trial | |||||
| NCT Number | NCT06359002 | Clinical Status | PHASE1 | ||
| Clinical Description |
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.
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| Primary Endpoint |
The study evaluates dose-limiting toxicities during initial 21 days and assesses composite complete remission rates (CR+CRh+CRi per ELN 2022) up to 24 months in dose escalation and expansion phases.
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| Other Endpoint |
Safety parameters include AE monitoring and dose modifications for 24 months, while pharmacokinetics (Cmax, Tmax, AUC) and immunogenicity (anti-drug antibodies) are tracked alongside efficacy measures (ORR, DoR, RFS, EFS, OS) using ELN 2022 criteria throughout the study period.
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References