Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia

Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of anti-FLT3 CAR T-cells targeting FLT3 to evaluate the safety and efficacy of anti-FLT3 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Inclusion Criteria:

• FLT3 positive relapsed/refractory acute myeloid leukemia
• Age 16-65 years.
• Left ventricular ejection fractions ≥ 0.5 by echocardiography
• Creatinine < 1.5x upper limit of normal.
• Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
• Total bilirubin ≤ 1.5x upper limit of normal
• Karnofsky performance status ≥ 60
• Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

• Patients are pregnant or lactating
• Uncontrolled active infection
• Grade 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 a history of seizure
• Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)