CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

Inclusion Criteria

• •Collection and Manufacturing Eligibility
• •Age \<21 years old
• •Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
• •\*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
• •* Second or greater relapse
• •* Any relapse after allogeneic HCT
• •* Refractory disease (primary or in relapse) despite therapy designed to induce remission
• •Estimated life expectancy of \> 12 weeks
• •Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
• •For females of childbearing age:
• •* Not lactating with intent to breastfeed
• •* Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
• •Age \< 21 years old
• •Detectable disease in the bone marrow
• •Estimated life expectancy of \> 8 weeks
• •Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A)
• •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 \>50 mL/min/1.73m2 (GFR \>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
• •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
• •Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion
• •For females of childbearing age:
• •* Not lactating with intent to breastfeed
• •* Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
• •* If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.