eligibility_summary
Inclusion: ≥18, ECOG 0–2, survival ≥3 mo, CD123+ AML (relapsed/refractory or MRD+), adequate organ function (liver/renal/coag, LVEF ≥50), contraception (12 mo), consent. Exclusion: CNS leukemia, Flu/Cy contraindication, systemic steroids <4 wks, active IV infection (HBV/HCV/HIV/syphilis/TB) <14 d, allergy to murine/biologics, pregnant/lactating, contraception noncompliance, severe autoimmune/immunodeficiency, mental illness, substance dependence, or deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: JD123 injection, an allogeneic, off-the-shelf CD123-directed chimeric antigen receptor natural killer (CAR-NK) cell therapy. Mechanism: NK cells are engineered with a CAR that binds CD123 (IL-3 receptor alpha) on AML blasts and leukemic stem cells, activating NK cytotoxicity (perforin/granzyme and death-receptor pathways) and cytokine-mediated killing, with inherently low GVHD risk. Preconditioning: fludarabine (purine analog) plus cyclophosphamide (alkylator) for lymphodepletion to enhance CAR-NK engraftment and persistence. Targets: CD123+ AML cells and MRD, pathway focus is IL-3Rα on leukemic cells and NK effector signaling. Study design: single-arm, dose-escalation (5.0×10^8 to 3.0×10^9 cells) after FC chemotherapy in relapsed/refractory CD123-positive AML.