CD19-CAR_Lenti in pediatric patients affected by relapsed/refractory B-ALL or aggressive B-NHL

You likely can't join if

• Procurement eligibility 1. Severe, uncontrolled active infections 2. HIV, or active HCV and/or HBV infection (detection of viral RNA/DNA in blood) 3. Previous allogeneic HSCT in the preceding 100 days before apheresis 4. Concurrent or recent prior therapies, before apheresis: a) Systemic steroids (at a dose equivalent to or greater 2 mg/kg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled/topical/nonabsorbable steroids is not exclusionary. b) Systemic chemotherapy in the 2 weeks preceding apheresis collection. c) Anti-thymocyte globulin (ATG) in the 4 weeks preceding apheresis collection. d) Immunosuppressive agents in the 2 weeks preceding apheresis collection. e) Radiation therapy must have been completed at least 1 week prior to apheresis. f) Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis (i.e., start of protocol therapy); Treatment eligibility 1. Pregnant or lactating women 2. Severe, uncontrolled active infections 3. HIV, or active HCV and/or HBV infection (detection of viral RNA/DNA in blood) 4. Life-expectancy < 6 weeks 5. Hepatic function: Inadequate liver function defined as total bilirubin > 4x upper limit of normal (ULN) or transaminase (ALT and AST) > 6 x ULN 6. Renal function: serum creatinine > 3x ULN for age. 7. Blood oxygen saturation < 90%. 8. Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO. 9. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject. 10. BM blasts > 50% pre-infusion. 11. Hyperleukocytosis (greater than or equal to 20,000 blasts/microliter) or rapidly progressive disease that in the evaluation of the investigator would compromise ability to complete study therapy 12. Presence of active, grade 2-4 acute or moderate-severe chronic GvHD 13. Recurrent or refractory ALL with testicular involvement 14. Concurrent or recent prior therapies, before infusion: a) Systemic steroids (at a dose > 2 mg/kg prednisone) in the 2 weeks before infusion. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary. b) Systemic chemotherapy in the week preceding infusion. c) Anti-thymocyte globulin (ATG) in the 4 weeks preceding infusion. d) Immunosuppressive agents in the 1 week preceding infusion. e) Radiation therapy must have been completed at least 3 weeks prior to enrollment. f) Other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion (i.e. start of protocol therapy); 15. Patient-derived CD19-CAR_Lenti production failure: vitality of the fresh product <80%, CD3+ cells <80%, CD3+ CAR+ cells <10%, non-sterility in IPC at day 5, endotoxin contamination (> 5 EU/ml) in IPC at day 5, mycoplasma contamination in IPC at day 5, failure of the visual inspection.