eligibility_summary
Patients ≤40 with high-risk AML. Cohort1: CR/MLFS with high-risk features (MRD/cytogenetics), ≥CR2, therapy-related AML in CR1, or AML from MDS, ≤1 prior HCT allowed. Cohort2: refractory AML or ≥2 post-HCT relapses, BM blasts <25%. PS >60%, adequate organ, cardiac, pulmonary, contraception. Requires haploidentical related donor ≥18 (≥5/10), 2 leukaphereses. Exclude: active GvHD, CNS/EM disease, immunosuppression, donor-specific HLA Abs, uncontrolled infection, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I/II pilot testing donor-derived cytokine-induced memory-like NK (ML NK) cells after TCRαβ/CD19-depleted haploidentical HCT in high-risk AML. Interventions and mechanisms: rATG (rabbit polyclonal antilymphocyte serum, T-cell depletion), busulfan, thiotepa, melphalan (alkylating agents, DNA crosslinking), fludarabine (purine analog, lymphodepleting). Day 0: TCRαβ/CD19-depleted hematopoietic progenitor graft via CliniMACS (immunomagnetic selection device). Day +7: ML NK infusion plus IL-2 (cytokine, expands/activates NK via IL-2R/JAK-STAT) for 7 doses. Donor mobilization: G-CSF (hematopoietic growth factor, CSF3R agonist) ± plerixafor (CXCR4 antagonist) to mobilize CD34+ cells. Targets/pathways: AML blasts via NK cytotoxicity (NKG2D/natural cytotoxicity receptors, perforin/granzyme, ADCC), depletion of TCRαβ T cells and CD19+ B cells to reduce GVHD, CXCL12–CXCR4 axis, and myeloablation/lymphodepletion to enable engraftment.