Engineered T-Cells take on childhood leukemia in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * CD19+ Leukemia in 1st marrow relapse with MRD at the end of 1st month of re-induction * CD19+ Leukemia in 2nd or greater relapse * CD19+ Leukemia with indication for HCT, but has contraindication * Age between 1 and 26 years of age * Karnofsky of \>50 or Lansky \>50 * Life Expectancy \>12 weeks * Able to tolerate a blood draw of 4-6mL/kg * Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy * absolute lymphocyte count of \>/=750 cell/mm3 or \>/=500 is \>20kg * creatinine clearance or radioisotope GFR \>/= 70mL/min/1.73m2 OR normal serum creatinine based on age/gender * total bilirubin \</= 1.5x upper limit normal OR direct bilirubin \</= 1.5mg/dl * ALT \</= 3x upper limit normal * corrected QTc \<450msec of ECG * Shortening Fraction \>28% by ECHO or Ejection Fraction \>50% by MUGA * Documented negative HIV, Hep B and Hep C * Agree to long-term follow up for up to 15 years if they receive T cell infusion Exclusion Criteria: * Philadelphia Positive Leukemia * Prior Allogeneic Stem Cell Transplant * CNS 2 or 3 * prior cellular immunotherapy with chimeric antigen receptor modified T cells * fully humanized antibodies within three half lives * systemic corticosteroids within 7 days of enrollment * requires supplemental oxygen or has a chest X-ray with an infectious process * CNS pathology (seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) * Pregnant or breastfeeding women. Female participant of reproductive age must have a negative pregnancy test and agree to contraception for 1 year after T cell infusion. * Active Malignancy other than CD19+ Leukemia * Active severe infection defined as a positive blood culture within 48 hours of study enrollment or a fever \>38.2C AND clinical signs of infection within 48 hours of study enrollment * Patient has a concurrent medical condition, that in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy. * Trisomy 21 * Primary immunodeficiency/bone marrow failure syndrome