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.
This is a single-center, randomized, open label phase I clinical trial to evaluate the efficacy and safety of ex-vivo expanded allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT. The infusion doses of γδ T cells were 2E8 cells/kg and 4E8 cells/kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Cells 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.
Institute of Hematology & Blood Diseases Hospital
Beijing, China
RECRUITINGObjective 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.
Time frame: 4weeks
MRD-negative rate at 2 weeks (CRMRD- rate)
Proportion of subjects achieving MRD negativity after 2 weeks of treatment.
Time frame: 2weeks
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.
Time frame: 4weeks
2-Year Overall Survival (OS)
Proportion of subjects who remain alive at 2 years from the first dose of study treatment.
Time frame: 2 years
Safety observation
Incidence of Grade ≥3 adverse events (AEs) Incidence of GVHD Non-relapse mortality (NRM)
Time frame: Baseline to 2 years
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