CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia

Inclusion Criteria

• •Autologous Apheresis and Manufacturing
• •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
• •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.