myeloid malignancies
Conditions
Interventions
Case series:third party health donor double negative T(DNT) cells
Sponsors
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any age, any gender, any race; 2. Myeloid malignancies including acute myeloid leukemia(AML)(except APL), myelodysplastic syndrome (MDS),myelodysplastic syndrome(MDS/MPD)/bone marrow hyperplastic disease, chronic myelogenous leukemia (CML), all patients were diagnosed through MICM (in accordance with the WHO diagnostic criteria); 3. All the patients were treated with HSCT; 4. The primary disease in patients was relapse after transplantation: leukemia cells were recurrence in peripheral blood or>5% in bone marrow(except for other reasons such as bone marrow recovery, etc.), or extramedullary leukemia cell infiltration or recurrence of molecular biology or genetics; 5. Karnofsky score 60% or higher, eastern group (ECOG) tumor physical status score 0 to 2 points; 6. In group 2 weeks before the serum total bilirubin <=1.5 times of normal cap (of the same age group);Alanine aminotransferase (ALT) and aspertate aminotransferase (AST) <=3times of normal cap (of the same age group); Serum creatinine<=2 times of normal cap (of the same age group); Myocardial enzyme < 2 times of normal cap (of the same age group); 7. Anti-HIV(-); 8. Each participant must sign a consent form (ICF), shows that he/she understand the study purpose and procedures, and are willing to participate in research; Considering from the patient, if the signature is not conducive to patient treatment, it is signed by the legal representative of ICF. Donor selection criteria: 1. Aged = 18 years; 2. Qualified health personnel who meet the blood donation requirements of the central blood station; 3. No disease transmitted through the blood system within 30 days before blood collection (HIV negative, HBsAg negative, HBV core antibody negative, hepatitis C antibody negative, syphilis serological test negative, CMV-IgM negative, EBV-IgM negative); 4. Previously performed DNT cells isolated and cultured in vitro, the cytotoxic effects of expanded DNT cells on at least three myeloid leukemia cell lines (OCI-AML3, MV4-11, K562, U937, etc.) were more than 20% (effective target ratio 4:1); 5. If the recipient primary leukemia cells can be obtained, the cytotoxic effect of the donor DNT cells on recipient primary leukemia cells (effect-target ratio 4:1) = 10%; 6. Try to select at least one of HLA-A2, A3, A9, A24, B7 or B27 mismatched between donors and recipients. (If the health donor cannot meet this requirement, both the recipient and the donor are willing to participate in the study, they can still be enrolled); 7. Agree to donate peripheral blood.
Exclusion criteria
Exclusion criteria: 1. Any serious complications, such as pulmonary infection, or diseases (such as uncontrolled diabetes, etc.); 2. Serious viscera dysfunction or disease, such as serious diseases and function disorder in heart, liver, kidney and pancreas; 3. suffered from II~IV acute GVHD or extensive chronic GVHD; 4. Systemic corticosteroids should be used in the cell infusion; 5. Patients with pregnancy; 6. Researchers believe that can damage the unnecessary risks to safety, make the results of the study subjects any life-threatening illness, condition or organ system dysfunction; drug dependence; uncontrolled mental disease ; cognitive impairment; 7. Participants and/or authorized family members refused to accept DNT immune cell therapy; 8. Participate in other clinical researches in 3 months; 9. Researchers think that the patient doesn't fit into the group (e.g., patients are expected to be discontinue because of funding problems); 10. The donor does not meet the requirements: chronic diseases that need to be treated(such as hypertension, diabetes, heart disease, thyroid disease and liver and kidney dysfunction), bone marrow disease,systemic corticosteroids must be used in Peripheral blood extraction,onset of mental illness, poison, drug addiction, refused to donate peripheral blood, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematopoietic cells recovery time ;Duration of CR;Early mortality;1 year overall survival;1 year leukemia free survival ;Minimal residual disease,WT - 1 gene, tumor gene, chromosome ebb and flow rate before and after treatment ; | — |
Countries
China
Contacts
Public ContactZimin Sun
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Outcome results
None listed