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Inclusion criteria only for B-ALL |
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Male or female aged 3-70 years |
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Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1) |
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Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions) |
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CR not achieved after standardized chemotherapy |
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CR achieved following the first induction, but CR duration is 12 months |
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Ineffectively after first or multiple remedial treatments |
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2 or more relapses |
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The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is5% (by morphology), and/or1% (by flow cytometry) |
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Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments |
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Inclusion criteria only for B-NHL |
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Male or female aged 18-70 years |
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Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016) |
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Relapsed or refractory B-NHL (meeting one of the following conditions) |
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No response or relapse after second-line or above chemotherapy regimens |
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Primary drug resistance |
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Relapse after auto-HSCT |
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At least one assessable tumor lesion per Lugano 2014 criteria |
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Common inclusion criteria for B-ALL and B-NHL |
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Total bilirubin 51 umol/L, ALT and AST 3 times of upper limit of normal, creatinine 176.8 umol/L |
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Echocardiogram shows left ventricular ejection fraction (LVEF) 50% |
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No active infection in the lungs, blood oxygen saturation in indoor air is 92% |
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Estimated survival time 3 months |
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ECOG performance status 0 to 2 |
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Patients or their legal guardians volunteer to participate in the study and sign the informed consent |
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Inclusion exclusion criteria only for B-ALL
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Extramedullary lesions, except that CNSL (CNS-1) has been effectively controlled
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Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/ lymphoma per WHO Classification Criteria
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Hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
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Inclusion exclusion criteria only for B-NHL
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Extranodal lesions in the brain (tumor cells in CSF, and/or MRI shows invasion of intracranial lymphoma)
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Extensive invasion of gastrointestinal lymphoma
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Common exclusion criteria for B-ALL and B-NHL
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History of hypersensitivity to any component of cell product
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Prior treatment with any CAR T cell product or other genetically-modified T cell therapies
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Prior treatment with radiotherapy, chemotherapy or mAb 1 week prior to apheresis
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New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1)
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Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment
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Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999)
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Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past
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History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases
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Severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
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Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed
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History of other primary cancer, except for the following conditions
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Cured non-melanoma after resection, such as basal cell carcinoma of the skin
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Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival 2 years after adequate treatment
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Autoimmune diseases requiring treatment, immunodeficiency or patients requiring immunosuppressive therapy
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Prior immunizations with live vaccine 4 weeks prior to screening
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History of alcoholism, drug abuse or mental illness
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If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B > 1000 (if HBV DNA copy number1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection
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Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids
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Patients who have participated in any other clinical studies within 2 weeks prior to screening
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Female pregnant or lactating, male for female fertile but unable to take medically acceptable contraception measures
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Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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