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Inclusion criteria applicable to ALL only |
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Male or female aged 3 and <70 years old |
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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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Ineffective after first or multiple remedial treatments |
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2 or more recurrences |
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The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (morphology) and/or >1% (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 applicable to NHL only |
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Male or female aged 18 and <70 years old |
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Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia/small lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma |
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Relapsed or refractory DLBCL (meeting one of the following conditions) |
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No remission or recurrence after receiving second-line or above second-line chemotherapy |
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Primary drug resistance |
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Recurrence after autologous hematopoietic stem cell transplantation |
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According to Lugano 2014, there should be at least one evaluable tumor lesion |
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Applicable standards for ALL and NHL |
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HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-) |
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total bilirubin 51umol/L, ALT and AST 3 times of upper limit of normal, creatinine 176.8umol/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 by sucking 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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patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only)
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Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only)
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Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only)
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patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only)
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extensive involvement of gastrointestinal lymphoma (for NHL patients only)
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radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening
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Have a history of allergy to any of the components in the cell products
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Prior treatment with any CAR T cell product or other genetically-modified T cell therapies
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According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency
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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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Patients with 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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Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy
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Patients with graft-versus-host disease (GVHD)
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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 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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pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender)
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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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