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Brief Title: A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Official Title: Phase 1/Phase 2 Study of IMM01 Combined With Azacitidine in Patients With AML and MDS
Study ID: NCT05140811
Brief Summary: 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).
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing gobroad boren hospital, Beijing, , China
Peking university third hospital, Beijing, , China
Xuanwu Hospital, Capital Medical University, Beijing, , China
Chongqing university cancer hospital, Chongqing, , China
Second Affliated Hospital of Army Medical University, Chongqing, , China
Fujian medical university union hospital, Fuzhou, , China
Ganzhou People's Hospital, Ganzhou, , China
Guangdong provincial people hospital, Guangzhou, , China
Nanfang Hospital, Southern Medical University, Guangzhou, , China
Zhujiang Hospital, Southern Medical University/The Second School of Clinical Medicine, Southern Medical University, Guangzhou, , China
The first affiliated hospital zhejiang university school of medicine, Hangzhou, , China
The first affiliated hospital of nanchang University, Nanchang, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, , China
Shanghai sixth's hospital, Shanghai, , China
Tongren hospital shanghai jiaotong university school of medicine, Shanghai, , China
Shengjing Hospital Affiliated to China Medical University, Shenyang, , China
The First Hospital of China Medical University, Shenyang, , China
Tianjin Blood Disease Hospital, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
The affiliated hospital of Xuzhou medical university, Xuzhou, , China
Henan Cancer Hospital, Zhengzhou, , China
The first affiliated hospital of Zhengzhou University, Zhengzhou, , China