Main study purpose:~To evaluate the safety and tolerability of IMM01 combined with Azacitidine in patients with AML and MDS.~To explore the Maximum Tolerated Dose (MTD) of IMM01 combined with Azacitidine, and determine the phase 2 clinical recommended dose (RP2D) of IMM01 combined with Azacitidine.~Secondary study purpose:~To evaluate the efficacy of IMM01 combined with Azacitidine in patients with AML and MDS.~To evaluate the Pharmacokinetics and Pharmacodynamics of IMM01 combined with Azacitidine, in patients with AML and MDS.~Exploratory study purpose:~• To evaluate the immunogenicity of IMM01 combined with Azacitidine in patients with AML and MDS.
This trial is an open-lable , multi-center, Phase 1/Phase 2 study that will evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and and immunogenicity of IMM01 combined with Azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).