Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
• Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows:
• Age 6-65 years.
• Left ventricular ejection fractions≥ 0.5 by echocardiography.
• Creatinine \< 1.6 mg/dL.
• Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
• Bilirubin \<2.0 mg/dL.
• Karnofsky performance status ≥ 60
• Expected survival time ≥ 3 months (according to investigator's judgement)