CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Exclusion Criteria39

• Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).
• Autologous or allogeneic HCT in 3 months prior to IMP administration.
• Severe, uncontrolled active infection.
• Life expectancy \< 6 weeks.
• Parenchymal central nervous system involvement.
• Respiratory insufficiency (need for oxygen therapy).
• Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4times normal upper limit.
• Acute kidney injury with serum creatinine \> 180 µmol/L, oliguria or need for acute dialysis.
• Heart failure with EF \< 30% by echocardiography.
• Presence of active grade 3-4 acute GvHD.
• Serious uncontrolled neurological comorbidity.
• Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.
• Women: pregnancy or breast-feeding.
• Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:
• female patients of childbearing potential not willing to use a highly effective method of contraception during the study,
• male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.
• Severe uncontrolled active infection.
• Positive test results for HIV1/2, Hepatitis B/C and lues.
• Concurrent or recent prior therapies before apheresis:
• Autologous or allogeneic hematopoietic cell transplantation within 12 weeks.
• Clofarabine, Fludarabine, Alemtuzumab within 8 weeks.
• Donor lymphocyte infusions within 4 weeks.
• Pegylated asparaginase within 4 weeks.
• Maintenance chemotherapy within 2 weeks.
• Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks.
• Vincristine within 2 weeks.
• Intrathecal methotrexate within 1 week.
• Granulocyte Colony Stimulating Factor (G-CSF) within 5 days.
• Therapeutic dose of corticosteroids within 3 days.
• Short-acting cytostatics within 3 days
• Severe, uncontrolled active infections.
• Life expectancy \< 6 weeks.
• Parenchymal central nervous system involvement
• Respiratory insufficiency (need for oxygen therapy).
• Significant liver impairment: bilirubin \> 50 µmol/L, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 4times normal upper limit.
• Acute kidney injury with serum creatinine \> 180 µg/L, oliguria or need for acute dialysis.
• Heart failure with Ejection Fraction (EF) \< 30% by echocardiography.
• Presence of active grade 3 - 4 acute GvHD
• Serious uncontrolled neurological comorbidity.