This study investigates the potential curative properties of ex-vivo expanded gamma delta T-cells obtained from a blood-related donor for patients with relapsed or refractory acute myeloid leukemia.
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T-lymphocytes in patients with relapsed or refractory acute myeloid leukemia. PBMCs will be separated from peripheral blood of suitable donors. After making them potential cancer killer γδ T Cells, they will be infused to the patients as an immunotherapy treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2\*10\^6, 4\*10\^6, 8\*10\^6 of cells per kg of body weight).
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGFour-months remission rate
Number of patients reaching Complete Remission (CR) according to National Comprehensive Cancer Network (NCCN, Version 1.2015).
Time frame: 4 months
Number of participants with adverse events (AEs)
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).
Time frame: 3 years
Overall survival
OS was calculated from the first infusion to death or last follow-up (censored).
Time frame: 3 years
Event-free survival
EFS was calculated from the first infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).
Time frame: 3 years
Relapse-free survival
RFS was calculated from the first infusion to relapse or last visit (censored).
Time frame: 3 years
Quantity of gamma-delta T cells in bone marrow cells and peripheral blood cells
Persistence of γδ T cells assessed by number and phenotype of γδ T cells using flow cytometry assay in peripheral blood and bone marrow from patients
Time frame: 3 years
lymphocyte subsets function assessment of bone marrow cells and peripheral blood cells
Assessment of lymphocyte subsets function using flow cytometry assay in peripheral blood and bone marrow from patients.
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Time frame: 3 years