Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
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.
Age
1–30
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
