MT2017-45: CAR-T Cell Therapy for Heme Malignancies

ARM A (Kymriah) and Arm G (Tecartus) :Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19 Inclusion Criteria: * Age and Disease Status * Must be age 0-25 years (for Arm A Kymriah) or \>18 years (Arm G Tecartus) * Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these: * Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or * Patients with persistent minimal residual disease (MRD \>0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or * Patients in 2nd or greater relapse of B-ALL or * Patients with persistent CNS leukemia, or * Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or * Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory. * Performance Status \* Arm A: Karnofsky (age ≥16 years) or Lansky (age \< 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2 * Organ Function * Renal function defined as: * A serum creatinine of ≤1.5 x ULN OR * eGFR ≥ 50 mL/min/1.73 m2 * Liver function defined as: \*\* ALT ≤ 5 times the ULN for age (unless due to disease) \*\* Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert sy…