Primary Outcome Measures
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]
Safety evaluation
Secondary Outcome Measures
- Clinical response [ Time Frame: 60 months ]
Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging. - CAR-T cells testing [ Time Frame: 60 months ]
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
- Inclusion Criteria
- If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
- Patients must be willing to sign an informed consent.
- Age: 4 to 70 years
- Estimated survival of ≥ 12 weeks, but ≤ 2 years
- Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A*0201 is required at the same time .
- Subjects with solid tumor must have measureable disease
- Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
- Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
- Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
- Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
- ECOG score ≤2
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Women of child-bearing age must have evidence of negative pregnancy test.
- Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
- Patients must be willing to sign an informed consent.
- Exclusion Criteria
- ECOG >= 3
- Patients with history of T cell tumors
- Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
- Acute or chronic GVHD after allogeneic hematopoiesis
- steroid hormones were used before and after blood collection and infusion
- HIV infection or active hepatitis B or hepatitis C infection
- Uncontrolled active infection
- Enrolled to other clinical study in the last 4 weeks.
- Subjects with systemic auto-immune disease or immunodeficiency.
- Subjects with CNS diseases.
- Other patients that researchers considered unsuitable for inclusion
- Patients with history of T cell tumors