A Phase 1b Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of BC3402 in Combination With Azacitidine in Subjects With Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• MDS and CMML subjects with higher risk;
• Age ≥ 18 years old;
• Eastern Cooperative Oncology Group score of 0\
⁃ 2;
• Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
• Subjects should take effective contraceptive measures
• Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Zijian Xiao, MD
zjxiao@ihcams.ac.cn
+86 13821085716
Backup
Bing Li, MD
libing@ihcams.ac.cn
+86 15522279160
Time Frame
Start Date: 2023-06-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 32
Treatments
Experimental: BC3402+azacitidine
Subjects will receive azacitidine and BC3402 in a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Biocity Biopharmaceutics Co., Ltd.