Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia
Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia
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.
Inclusion Criteria:

 1. History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more
 blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in
 peripheral blood or bone marrow)

 2. Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML
 relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose
 cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low
 intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy.

 3. Presence of > 5% of blasts in bone marrow or peripheral blood smear

 4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or
 allogeneic Haematopoietic Cell Transplantation (HCT)

 5. Considered suitable for lymphodepleting chemotherapy

 6. The patient's peripheral superficial venous blood flow smoothly, which can meet the
 needs of intravenous drip.

 7. Patient's main organs function well. A. Liver function: ALT/AST < 3 times the upper
 limit of normal (ULN); B. total bilirubin≤34.2μmol/L; C. Renal function: Creatinine <
 220μmol/L; D. Pulmonary function: Indoor oxygen saturation≥95%; E. Cardiac Function:
 Left ventricular ejection fraction (LVEF) ≥40%;

 8. Life expectancy of at least 3 months

 9. Patient ECOG score≤2, Estimated survival time≥3 months.

 10. Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3
 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.

 11. The patients did not receive any anticancer treatments such as chemotherapy,
 radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before
 admission, and the toxicity related to previous treatments had returned to < 1 level
 at admission (except for low toxicity such as alopecia).

 12. Patient able to understand and sign written informed consent

 13. Age 18 years up to the age of 75 (≤ 75)

 Exclusion Criteria:

 1. Women who are pregnant (urine/blood pregnancy test positive) or lactating.

 2. Male or female with a conception plan in the past 1 years.

 3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.)
 within 1 years after enrollment.

 4. Uncontrolled infectious disease within 4 weeks prior to enrollment.

 5. Active hepatitis B/C virus.

 6. HIV infected patients.

 7. Suffering from a serious autoimmune disease or immunodeficiency disease.

 8. The patient is allergic and is allergic to macromolecular biopharmaceuticals such as
 antibodies or cytokines.

 9. The patient participated in other clinical trials within 6 weeks prior to enrollment.

 10. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with
 inhaled corticosteroids).

 11. Have a history of epilepsy or other central nervous system diseases.

 12. Having drug abuse/addiction.

 13. According to the researcher's judgment, the patient has other unsuitable grouping
 conditions.