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

Más betegség

• Severe uncontrolled active infection.
• Positive test results for HIV1/2, Hepatitis B/C and lues.
• Severe, uncontrolled active infections.
• Respiratory insufficiency (need for oxygen therapy).

Laborértékek

• 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
• 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.

Egyéb

• Life expectancy < 6 weeks.
• Parenchymal central nervous system involvement
• Presence of active grade 3 - 4 acute GvHD
• Serious uncontrolled neurological comorbidity.

• Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
  • B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR
  • B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR
  • B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).
• CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
• Age ≥18 years and ≤ 80 yearss.
• Patient able to understand and sign informed consent.
• Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.
  • General Exclusion Criteria:
• 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.