CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia

Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Inclusion Criteria:

• CD38 positive relapsed/refractory acute myeloid leukemia
• 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
• Total bilirubin <2.0 mg/dL
• karnofsky performance status ≥ 60
• expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

• patients are pregnant or lactating
• uncontrolled active infection
• class III/IV cardiovascular disability according to the New York Heart Association Classification
• active hepatitis B or hepatitis C infection
• patients with HIV infection
• patients with history of seizure
• active central nervous system leukemia