Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma

Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults

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.

Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.

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.