This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Age ≥ 18 years old,;
Expected survival period ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
Central nervous system involved;
Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
Single group
NK cell
DrugDrug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs)
Treatment-related adverse events
Treatment-related adverse events
Complete response (CR)
Complete response (CR)
Proportion of subjects with minimal-residual disease (MRD) negative response
Peak levels of donor NK cells (maximum concentration or Cmax)
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