eligibility_summary
Key eligibility: CD123+ AML (2016 WHO), in 1st–3rd relapse or primary refractory after standard induction/HMA, with ≤3 prior regimens. Prior auto/allo transplant allowed if allo >3 months, no active GVHD, off GVHD meds >28 days. Exclude: BCR‑ABL+ leukemia, APL, JMML, severe allergy to mAbs/AFM28, recent therapy (≤14 d, biologics ≤28 d) or radionuclides ≤6 wks, unresolved ≥grade 2 toxicity, active/suspected CNS leukemia, other malignancy unless cured ≥2 y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05817058. Intervention: AFM28, a bispecific tetravalent monoclonal antibody (Immune Cell Engager, ICE). Drug type: antibody-based biologic. Mechanism of action: simultaneously binds CD123 (IL3RA) on AML cells and CD16A (FcγRIIIa/FCGR3A) on innate immune cells, primarily NK cells, to trigger antibody‑dependent cell‑mediated cytotoxicity (ADCC) and kill CD123+ leukemic cells. Administration: weekly IV, Phase 1 dose‑escalation to define MTD/RP2D with PK/PD and safety. Targets/cells/pathways: CD123-expressing AML blasts (IL‑3 receptor alpha), activation of NK cells via CD16A/FcγRIIIa signaling leading to ADCC. Population: adults with relapsed/refractory CD123+ AML. Status: terminated by sponsor.