Clinical Study on the Efficacy and Safety of Allogeneic γδ T Cells in the Treatment of Patients With MRD-positive Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT.
• Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
• Age≥18 years old, gender unlimited.
• All the subjects met the 2016 WHO classification and were diagnosed with AML via MICM (Morphology,Immunophenotyping, Cytogenetics, and Molecular genetics).
• AML patients receiving allo-HSCT.
• Subjects classified into the favorable -to-intermediate risk group according to the 2022 European Leukemia Net (ELN) risk stratification guidelines.
• All subjects were detected positive for MRD, and MRD was positive by flow cytometry (MFC) or/and positive for fusion genes/gene mutations by RQ-PCR.
• ECOG performance status score: 0-2.
• Inactive GVHD (acute GVHD grade II-IV or moderate to severe chronic GVHD).
• Adequate bone marrow reserve, defined as: absolute neutrophil count (ANC) \> 0.5E9/L and platelet count ≥20E9/L.
⁃ Adequate organ function as per protocol.
⁃ Male and female patients of reproductive potential must agree to use birth control during the study and for at least 28 days post study.