CD19??/CD22????????B???????
Conditions
Interventions
Low dose (B-ALL):The infusion of 0.5×10^6 CART+ cell/kg
High dose (B-ALL):The infusion of 1.0×10^6 CART+ cell/kg
Low dose (B-NHL):The infusion of 1.0×10^6 CART+ cell/kg
Intermediate dose (B-NHL):The infusion of 3.0×10^6 CART+ cell/kg
High dose (B-NHL):The infusion of 6.0×10^6 CART+ cell/kg
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all only: 1. Aged >= 3 and = 50%; 4. The subjects did not receive radiotherapy, chemotherapy, monoclonal antibody or other anti-tumor treatment within one week before screening; 5. The estimated survival time is more than 3 months; 6. ECoG score 0-2; 7. The subjects or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed as chronic myeloid leukemia lymphoblastic crisis according to WHO classification; (only applicable to all patients); 2. Patients with hereditary syndromes, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; (for all patients only) 3. Subjects with extensive involvement of gastrointestinal lymphoma; (only applicable to NHL patients) 4. Subjects with allergic history to any component in cell products; 5. According to the NYHA cardiac function classification standard, subjects with cardiac insufficiency of grade III or IV; 6. Patients with myocardial infarction, angioplasty or stenting, unstable angina pectoris or other serious heart diseases within 12 months after admission; 7. The patients with QT interval prolongation indicated by ECG were those with severe heart disease such as severe arrhythmia; 8. Patients with severe active infection and without effective control (except simple urinary tract infection and bacterial pharyngitis); 9. Patients with a history of other primary cancers, except for the following: (1) Non melanoma, such as basal cell carcinoma, can be cured by resection; (2) Cervical carcinoma in situ, local prostate cancer and ductal carcinoma in situ with disease-free survival more than 2 years after adequate treatment; 10. Subjects with autoimmune diseases requiring treatment, subjects with immunodeficiency or requiring immunosuppressive therapy; 11. Patients with graft versus host disease (GVHD); 12. Screening the objects who had live vaccine in the first 4 weeks; 13. Subjects with a history of alcohol abuse, drug abuse or mental illness; 14. Subjects whose HBV and CMV DNA copy numbers are higher than the upper limit of normal value, and active syphilis and HIV infected persons; 15. The subjects who used steroids within one week before screening (except those who used local steroids or inhaled steroids); 16. The subjects who participated in other clinical trials within 2 weeks before screening; 17. Pregnant, lactating women and fertile subjects (both men and women) who cannot take effective contraceptive measures; 18. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT;TEAEs; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed