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Spots Global Cancer Trial Database for A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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Trial Identification

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

Interventions

IMM01
Azacitidine

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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