Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation;
- Age criteria: 18-65 years;
- Weight criteria: > 40kg;
Organ function criteria:
Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
- Life expectancy of at least 4 months;
- ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
- Patients able to understand and sign written informed consent.
Exclusion Criteria:
- GVHD (graft versus host disease) ≥ grade Ⅱ;
- Thrombotic microangiopathy;
- Posttransplant lymphoproliferative disorders;
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician);
- Patients with chronic diseases that require treatment with immune agents or hormones;
- Suffering from systemic autoimmune disease or immunodeficiency disease;
- Systemic use of steroids;
- Allergic constitution;
- Hemorrhagic disease or coagulation disorders;
- Patients participating in other clinical trials within 30 days prior to enrollment;
- Patients receiving radiotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women;
- According to the researcher's judgment, the patient has other unsuitable conditions.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Patients with hematological malignancies after allo-HSCT
Patients with negative minimal residual disease or stable disease: After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. Patients with positive minimal residual disease but not hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. Patients with hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.