CART22 Alone or in Combination With huCART19 for ALL

Inclusion Criteria

• •\- 1. Patients with relapsed or refractory B cell ALL:
• •a. Patients with 2nd or greater relapse or refractory to 1st salvage as defined by: i. Recurrent disease in the bone marrow identified morphologically, by immunohistochemistry or by Flow cytometry.
• •c. Patients with Ph+ ALL are eligible provided they are intolerant to or have failed tyrosine kinase inhibitor therapy.
• •d. Patients with prior or current history of CNS3 disease\* will be eligible only if CNS disease is responsive to therapy.
• •i. \*CNS disease definitions:
• •1. CNS1 - no blasts seen on cytocentrifuge (CNS negative);
• •2. CNS2 - total nucleated cell count \<5x106/L, but blasts seen on cytocentrifuge;
• •3. CNS3 - total nucleated cell count 5x106/L with blasts on cytocentrifuge and/or signs of CNS leukemia (i.e. cranial nerve palsy).
• •* 2\. For Cohort 1: Documentation of CD22 expression on malignant cells at relapse. For Cohort 2: Documentation of CD22 and/or CD19
• •* 3\. Adequate vital organ function defined as:
• •1. Creatinine ≤ 1.6 mg/dl
• •2. ALT/AST ≤ 3x upper limit of normal range
• •3. Total or Direct bilirubin ≤ 2.0 mg/dl. If Total bilirubin is ≤2.0, Direct bilirubin does not need to be assessed.
• •4. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
• •* 4\. Male or female age ≥ 18 years.
• •* 5\. ECOG Performance Status that is either 0 or 1.
• •* 6\. No contraindications for leukapheresis.
• •* 7\. Subjects of reproductive potential must agree to use acceptable birth control methods.