Back to resultsStudy of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
Primary Purpose
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BC3402
Azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Prior exposure to anti-TIM-3 therapy at any time Previous HSCT Live vaccine administered within 4 weeks prior to start of treatment 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.
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BC3402+azacitidine
Arm Description
Subjects will receive azacitidine and BC3402 in a treatment cycle.
Outcomes
Primary Outcome Measures
Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
To evaluate the safety and tolerability of BC3402
Secondary Outcome Measures
Full Information
NCT ID
NCT05970822
First Posted
July 13, 2023
Last Updated
July 30, 2023
Sponsor
Biocity Biopharmaceutics Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05970822
Brief Title
Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocity Biopharmaceutics Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BC3402+azacitidine
Arm Type
Experimental
Arm Description
Subjects will receive azacitidine and BC3402 in a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
BC3402
Intervention Description
Escalating of BC3402 will be administered IV(intravenous)
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Azacitidine will be administered daily
Primary Outcome Measure Information:
Title
Number of patients with AEs and SAEs Primary endpoint:Incidence of dose limiting toxiecities(DLTs) and incidence of DLT events within 28 days (first cycle)
Description
To evaluate the safety and tolerability of BC3402
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Prior exposure to anti-TIM-3 therapy at any time
Previous HSCT
Live vaccine administered within 4 weeks prior to start of treatment
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zijian Xiao, MD
Phone
+86 13821085716
Email
zjxiao@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Li, MD
Phone
+86 15522279160
Email
libing@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhijian Xiao, MD
Organizational Affiliation
Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhijian Xiao, MD
Phone
+86 13821085716
Email
zjxiao@ihcams.ac.cn
12. IPD Sharing Statement
Learn more about this trial
Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
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