A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma

Inclusion Criteria

• •Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
• •1. no available curative treatment options (such as autologous or allogeneic SCT)
• •2. If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
• •3. Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
• •4. Patients must be willing to sign an informed consent.
• •5. Age:≤18 years.
• •6. survival\>12 weeks
• •7. Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
• •8. Routine blood test:hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
• •9. Liver function: ALT and AST≤2.5 (ULN) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 ULN), bilirubin \<2.0 mg/dl.
• •10. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
• •11. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
• •12. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
• •13. ECOG score ≤2。
• •14. Adequate venous access for apheresis, and no other contraindications for leukapheresis