A Clinical Study of Chimeric Antigen Receptor T Cells Combined With Eps8 Peptide Specific Dendritic Cell for Patients With Relapsed/Refractory Leukemia and Myelodysplastic Syndromes
The main purpose of this study is to verify the safety and potential effectiveness of CART cells combined with peptide specific dendritic cell in relapsed/refractory leukemia.
• Tumor type: Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) according to the WHO criteria (at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count \> 10% and/or \> 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
• Positive antigen for any of CD19, CD20, CD22, CD10, CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.Simultaneously ,high expression of EPS8 or WT1 in acute leukemia.
• Relapsed/Refractory leukemia patients：
‣ Did not achieve complete remission after 2 times of standard plan chemotherapy.
⁃ Relapsed after first induction chemotherapy.
⁃ Did not response to chemotherapy before HSCT or relapsed after HSCT.
⁃ Cannot receive allo-HSCT or refuse to receive allo-HSCT.
⁃ Relapsed after CAR-T cell infusion.
• Age greater than 18 year and less than 80 years.
• Objectively assessable parameters of life expectancy: more than 3 months.
• Performance status: WHO PS grade 0-1 (ECOG performance status 0 or 1).
• Meet the following criteria for apheresis：WBC \>= 3,000/L, Hb \>= 8.0 g/dL, platelet count \>= 80,000/mm3, \<= 600,000/mm3.
• Pulmonary function: Peripheral blood oxygen saturation greater than 90%; Cardiac function: Left ventricular ejection fraction \>60%.
• Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV.
⁃ No concomitant use of immunosuppressive drugs.
⁃ Adequate renal and liver function, i.e. creatinin, bilirubin, and aminotransferase =\< 1.2 times the upper limit of normal.
⁃ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
⁃ Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
⁃ Written informed consent obtained.