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|NCT03638206 : Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies|
|Phase||Phase 1/Phase 2|
|Ages||Min: 4 Years Max: 70 Years|
1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
2. Patients must be willing to sign an informed consent.
3. age: 4 to 70 years
4. Estimated survival of = 12 weeks, but = 2 years
5. 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 .
6. Subjects with solid tumor must have measureable disease
7. Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
8. Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal;
endogenous creatinine clearance rate>=50 ml/min
9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver
cancer were excluded)
10. Cardiac function: stable hemodynamic and left ventricular ejection fraction
11. ECOG score =2
12. Adequate venous access for apheresis, and no other contraindications for leukapheresis
13. Women of child-bearing age must have evidence of negative pregnancy test.
14. Subjects of reproductive potential must agree to use acceptable birth control methods
within 1 year after treatment, as described in protocol.
1. ECOG >= 3
2. Patients with history of T cell tumors
3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
4. Acute or chronic GVHD after allogeneic hematopoiesis
5. steroid hormoneswere used before and after blood collection and infusion
6. HIV infection or active hepatitis B or hepatitis C infection
7. Uncontrolled active infection
8. Enrolled to other clinical study in the last 4 weeks.
9. Subjects with systemic auto-immune disease or immunodeficiency.
10. Subjects with CNS diseases.
11. Other patients that researchers considered unsuitable for inclusion
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03638206
| Link to official Clinicaltrials.gov listing