Status:
SUSPENDED
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
Eligibility Criteria
Inclusion
- MDS subjects with higher risk;
- Age ≥ 18 years old;
- Eastern Cooperative Oncology Group score of 0\~1;
- Not suitable for or refuse to receive HSCT;
- Newly diagnosed MDS subjects;
- Adequate organ function;
- Subjects should take effective contraceptive measures
- Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion
- Subject who has transformed from MDS to AML.
- Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Subjects participating in another interventional clinical study.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04485065
Start Date
September 30 2020
End Date
August 20 2024
Last Update
February 16 2023
Active Locations (1)
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1
Blood Diseases Hospital Chinese Academy Of Medical Science
Tianjin, China