Acute Lymphoblastic Leukemia (ALL) Clinical Trials

• Participants must have relapsed, or refractory ALL treated with at least one lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.

• \- Participant with Philadelphia Chromosome positive ALL are eligible if the progressed, had stable disease or relapsed after one line of therapy including tyrosine kinase inhibitors (TKIs)

• The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis

• Age 1 - 18 years

• Sex: Male or Female

• Performance status: Lansky or Karnofsky score greater than or equal to 50

• Normal organ function:

‣ AST (SGOT) less 5 times the upper limit of normal (ULN)

⁃ ALT (SGPT) less 5 times the upper limit of normal (ULN)

⁃ Total bilirubin less 3 times the upper limit of normal (ULN)

⁃ Creatinine less 5 times the upper limit of normal (ULN)

⁃ SpO2 room air greater than or equal to 90%

• Prior therapy wash-out before planned leukapheresis 7.1 Greater than or equal to 7 days post last chemotherapy/biologic therapy administration 7.2 Three half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy 7.3 At least 30 days from most recent cellular infusion 7.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed

• Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document