Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 1/Phase 2 Study 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).
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. ;
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