Status:
UNKNOWN
Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML
Lead Sponsor:
Biocity Biopharmaceutics Co., Ltd.
Conditions:
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 myelomonocy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05970822
Start Date
June 18 2023
End Date
December 1 2025
Last Update
August 1 2023
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300011