Clinical Research Directory

Autologous Apheresis and Manufacturing Inclusion Criteria: * CD19+ leukemia\*\* with any of the following: * Refractory disease (primary or in relapse) * 2nd or greater relapse * Any relapse after allogeneic hematopoietic cell transplantation * 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT * must be confirmed to be CD19+ within 3 months prior to enrollment for treatment * Age: ≤ 21 years of age * Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A) * Estimated life expectancy of \> 12 weeks. 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: * Known primary immunodeficiency * History of HIV infection * Severe intercurrent bacterial, viral or fungal infection * History of hypersensitivity reactions to murine protein-containing products * Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen Treatment Inclusion Criteria: * Age: ≤ 21 years of age * Estimated life expectancy of \> 8 weeks * Detectable disease * Prior to planned CAR T cell infusion, patients with a history of prior allogeneic HCT must: * be at least 3 months from HCT * have no evidence of active GVHD * have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion * Adequate cardiac function defined as left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25% * EKG without evidence of clinically significant arrhythmia * Adequate renal function defined as creatinine clearance or radioisotope GFR ³ 50 ml/min/1.73m2 (GFR ³ 40 ml/min/1.73m2 if \< 2 years of age) * Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing * Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A) * Total Bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age * Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy * For patients of child bearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment * If sexually active, agreement to use birth control until 6 months after T cell infusion. Exclusion Criteria: * Active CNS-3 disease * Known primary immunodeficiency * History of HIV infection * Evidence of active, uncontrolled neurologic disease * Severe, uncontrolled bacterial, viral or fungal infection * History of hypersensitivity reactions to murine protein-containing products * Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen