Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 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 anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Inclusion Criteria:

• CLL1 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