Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia

Inclusion Criteria for Autologous Apheresis: * Age ≤ 21 years old * CD19+ ALL with any of the following: * Minimal Residual Disease (MRD) ≥ 1% at end of up-front induction therapy * Hypodiploid (\< 44 chromosomes or \< 0.95 DNA index) CD19+ ALL with detectable disease at the end of up-front induction therapy * Increase in disease burden any time after the completion of up-front induction therapy * Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission * Refractory disease despite salvage therapy * 1st or greater relapse * Estimated life expectancy of \> 12 weeks * Karnofsky or Lansky (age-dependent) performance score ≥ 50 * Patients with a history of prior allogeneic hematopoietic cell transplantation \[HCT\] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis * For females of child bearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment Exclusion Criteria for Autologous Apheresis: * Known primary immunodeficiency * History of HIV infection * Severe intercurrent bacterial, viral or fungal infection * History of hypersensitivity reactions to murine protein-containing products Eligibility Criteria for Manufacturing SJCAR19: * CD19+ ALL with any of the following: * Primary refractory …