Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Trial Parameters
Brief Summary
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Eligibility Criteria
Inclusion Criteria: * CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma; * Karnofsky or Lansky performance scale greater or equal to 70; * T-cells count in peripheral blood \>150 cells/µL; * Written informed consent. Exclusion Criteria: * primary immunodeficiencies or genetic syndromes; * neurologic diseases; * autoimmune diseases or polyallergie; * transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion; * GvHD grade 2-4; * uncontrolled systemic infection; * hypoxia (Sp02\<90%) * severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age; * renal dysfunction: serum creatinine level \>=3x upper limit of normal for age; * positive serology for human immunodeficiency virus (HIV), active hepatite C or B; * pregnancy.