MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia

Exclusion Criteria

• •Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
• •Persistent extramedullary disease.
• •Isolated CNS and/or testicular disease.
• •Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
• •Active hepatitis B, C or HIV
• •Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
• •History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.
• •Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \< 65%) or an oxygen requirement of \>28% O2 FiO2 or active pulmonary infection.
• •Cardiac function: Left ventricular ejection fraction \<50% by echocardiography
• •Renal function: Creatinine clearance \<50 mL/min/1.73 m2
• •Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.
• •Pregnant or breast-feeding females
• •Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte