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.
Post-transplant relapse or extramedullary disease: AML patients post-allo-HSCT with ≥5% blasts in peripheral blood or bone marrow (excluding causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia infiltration.
Active GVHD: Subjects with active GVHD within 30 days before screening.
Active infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection.
Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease.
Single group
Ex-vivo expanded allogeneic γδ T cells
Biological/VaccineCells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδ T cells from donors will be adoptively transfused.
Objective Response Rate (ORR)
Defined as the MRD-negative complete remission rate (CRMRD- rate) at 4 weeks, representing the proportion of subjects achieving MRD negativity after 4 weeks of treatment.
MRD-negative rate at 2 weeks (CRMRD- rate)
Proportion of subjects achieving MRD negativity after 2 weeks of treatment.
Duration of Response (DOR)
Time from the first documented MRD-negative complete remission (CRMRD-) to the first occurrence of disease progression or death from any cause. For subjects without confirmed progression or death, DOR will be censored at the last evaluable assessment.
2-Year Overall Survival (OS)
Proportion of subjects who remain alive at 2 years from the first dose of study treatment.
Safety observation
Incidence of Grade ≥3 adverse events (AEs) Incidence of GVHD Non-relapse mortality (NRM)
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