Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Inclusion Criteria:

• Age ≥ 50 years
• Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

• Previous treatment with investigational gene or cell therapy medicine products
• CD33 negative leukemia
• Any uncontrolled active medical disorder that would preclude participation as outlined
• Pregnant or lactating women