cd19 car-t cell therapy for relapsed/refractory b-cell lymphoma and b-cell acute lymphoblastic leukemia

Conditions: B Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia

Summary: the primary objective of this study is to evaluate the safety and clinical activity of anti-cd19 chimeric antigen receptor t cells (kd-019 car-t)infusion in the treatment of relapsed/refractory b-cell lymphoma and b-cell acute lymphoblastic leukemia （b-all）.

the investigators designed an kd-019 chimeric antigen receptor(car) with fmc63 single-chain antibody fragment (scfv). this car has a cd8 hinge and transmembrane domains and a 4-1bb costimulatory domain; t cells expressing this car release relatively low levels of cytokines. subjects with relapsed/refractory cd19-positive b-cell lymphoma and b-all can participate if all eligibility criteria are met. subjects receive chemotherapy prior to the infusion of kd-019 car-t cells. after the infusion, subjects will accept follow-up for side effects and effect of kd-019 car-t cells by the sponsor. study procedures may be performed while hospitalized.

Eligibility criteria:
inclusion criteria: 1. patients or their legal guardians voluntarily participate and sign the informed consent document; 2. 18 years and older, male and female; 3. pathologically and histologically confirmed cd19 + b cell tumors; patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; or patients voluntarily choose transfusion of anti-cd19 car-t cells as the first treatment program; b-cell tumors / lymphomas and b-cell acute lymphoblastic leukemia include the following four types: 1. b-cell acute lymphoblastic leukemia; 2. indolent b-cell lymphomas; 3. aggressive b-cell lymphoma; 4、 subjects: (1) residual lesions remain after treatment; (2) not suitable for hematopoietic stem cell transplantation (auto/allo-hsct); (3) relapse after complement receptor 1 (cr1) and unsuitable for hsct; (4) patients with high risk factors; (5) relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy. 5、 have measurable or evaluable tumor foci; 6、 liver, kidney and cardiopulmonary functions meet the following requirements: 1. serum glutamic pyruvic transaminase (alt) and serum glutamic oxaloacetic transaminase (ast) \<3 ×upper limit of normal (uln); 2. total bilirubin ≤34.2μmol/l; 3. serum creatinine\<220μmol/l; 4. baseline oxygen saturation≥95%; 5. left ventricular ejection fraction（lvef）≥40%. 7、 subjects who did not receive chemotherapy, radiotherapy, immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、clinical performance status of eastern cancer cooperation group (ecog) score ≤2，expected survival≥3 months; exclusion criteria: 1. pregnant (urine/blood pregnancy test positive) or lactating women; 2. planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion; 3. patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment; 4. active or uncontrollable infection within four weeks prior to enrollment; 5. patients with active hepatitis b/c; 6. hiv-infected patients; 7. severe autoimmune or immunodeficiency disorders; 8. patients are allergic to macromolecule drugs such as antigens or cytokines; 9. subjects participated in other clinical trials within 6 weeks before enrollment; 10. systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); 11. mental illness; 12. drug abuse/addiction; 13. the investigators consider other conditions unsuitable for enrollment.