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Trial Title:
Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
NCT ID:
NCT05970822
Condition:
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Conditions: Official terms:
Leukemia
Preleukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Azacitidine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BC3402
Description:
Escalating of BC3402 will be administered IV(intravenous)
Arm group label:
BC3402+azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Azacitidine will be administered daily
Arm group label:
BC3402+azacitidine
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)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. MDS and CMML subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0~2;
4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT);
5. Subjects should take effective contraceptive measures
6. Must sign the Informed Consent Form (ICF), and be able to follow all study
procedures.
Exclusion Criteria:
1. Prior exposure to anti-TIM-3 therapy at any time
2. Previous HSCT
3. Live vaccine administered within 4 weeks prior to start of treatment
4. Current use or use within 7 days prior to start of treatment of systemic steroid
therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy.
Topical, inhaled, nasal, ophthalmic steroids are allowed.
Other protocol-defined Inclusion/Exclusion may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300011
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijian Xiao, MD
Phone:
+86 13821085716
Email:
zjxiao@ihcams.ac.cn
Start date:
June 18, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Biocity Biopharmaceutics Co., Ltd.
Agency class:
Industry
Source:
Biocity Biopharmaceutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970822
