safety and efficacy evaluation of next-generation cd19-ucart

Conditions: Acute Lymphoblastic Leukemia; Non Hodgkin Lymphoma

Summary: the purpose of this study is to evaluate the safety and efficacy of next-generation cd19-ucart in patients with relapsed or refractory b-cell hematological malignancies.

cd19-ucart is a kind of "off-the-shelf" product originated from health donor's pbmc. this is an open-label, single arm study to evaluate the safety and anti- tumor efficacy of next-generation cd19-ucart in the treatment of relapsed or refractory b-cell hematological malignancies.

Eligibility criteria:
inclusion criteria: 1. voluntary to participate in this clinical study and sign informed consent form; 2. the expected survival period is at least three months; 3. there is no other severe cardiopulmonary disease, and the liver and kidney function are normal (except for the subject with tumor lesions in the liver and kidney); 4. patients cannot benefit from autologous car-t cell therapy due to t cell separation failure or cart amplification failure in the preparation of autologous cart, or the failure to complete apheresis or disease progression; or the content of t cells in pbmc of peripheral blood is less than or equal to 10%; or the disease is not effectively controlled within one month after autologous car-t transfusion, and the patient cannot receive car-t transfusion again; 5. the test results show that cd19 is positive in the tumor; 6. patients with relapsed or refractory cd19-positive acute b-lymphocyte leukemia or b-cell non-hodgkin's lymphoma. patients with r/r b-all: 1 years old ≤ patient age ≤60 years. patients with r/r b-nhl: 18 years old ≤ patient age ≤65 years old 7. hematological indicators meet the following conditions: 1) wbc count ≥ 1.5× 10\^9/l; 2) absolute value of neutrophils ≥ 0.8× 10\^9/l; 3) lymphocyte count ≥ 0.1× 10\^9/l; 4) hemoglobin ≥ 60 g/l; 5) platelet count ≥ 20× 10\^9/l; 8. blood biochemistry shall meet the following requirements 1) or 2): 1) patients with liver and kidney without tumor lesions: a) total bilirubin (tbil)≤1.5\*uln (upper limit of normal value), unless suffering from gilbert's syndrome; b) aspartate aminotransferase (ast) ≤ 1.5 \* uln; c) alt ≤ 1.5 \* uln; d) scr ≤ 1.5 \* uln; e) urea (ura) ≤ 1.5 \* uln; 2) patients with liver and kidney tumor lesions: a) tbil≤5\*uln； b) ast≤5\*uln； c) alt≤5\*uln； d) scr≤5\*uln； e) urea≤5\*uln； 9. heart function: good hemodynamic stability, and the left ventricular ejection fraction (lvef) is higher than or equal to 55%; 10. serum viruses such as hiv, tp, hbv(hbv-dna) and hcv(hcv-dna) are all negative; 11. ecog activity status score: 0-2 points; 12. accept the requirement that effective contraception be used throughout the study; 13. willing to abide by the rules established in this study. exclusion criteria: 1. pregnant or lactating women; 2. having a pregnancy plan in the next two years; 3. has received graft-versus-host disease treatment in the past; 4. has received allogeneic cell therapy in the past 6 weeks; 5. has received allogeneic stem cell transplantation within the past 6 months; 6. individual extramedullary relapse b-all; 7. suffering from severe mental disorder; 8. active autoimmune diseases requiring immunotherapy; 9. has suffered from other malignant tumors in the past; 10. patients with severe cardiovascular disease; 11. prothrombin time or activated partial thromboplastin time or international normalized ratio \> \>1.5\*uln； in the absence of anticoagulant therapy; 12. there is active infectious disease or need any major infection events of high-level antibiotics; 13. any condition that, in the opinion of the investigator, may increase the subject's risk or interfere with the study results.