GD2-CAR T Cells for Pediatric Brain Tumours

Exclusion Criteria17

• Pregnant or lactating women
• Severe,uncontrolledactiveinfections
• HIV or active HCV and/or HBV infection
• Rapidly progressive disease with life expectancy \< 6 weeks
• Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts
• Hepatic function: inadequate liver function defined as total bilirubin \> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \> 6 x ULN based on age and laboratory specific normal ranges
• Renal function: serum creatinine \> 3x ULN for age
• Blood oxygen saturation \< 90%
• Cardiac function: left ventricular ejection fraction lower than 45% by ECHO
• Marrow function: absolute neutrophils count (ANC) lower than 500/mm3 and/or platelets lower than 20.000 (not reached by transfusion)
• Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:
• If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled/topical/non- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis
• Systemic chemotherapy in the 3 weeks preceding infusion
• Immunosuppressive agents less than or equal to 30 days
• Radiation therapy must have been completed at least 6 weeks prior to enrollment
• Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy
• Patient-derived GD2-CART01 production failure: vitality \<80%, CD3+ cells \<80%, CD3+ CAR+ cells \<20%, CD3+ CAR+ antitumor activity \<60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \>20%, RCR positivity, Vector Copy Number \>10, non-sterility, endotoxin contamination (\> 1 EU/ml)