Efficacy and Safety Evaluation of IBI188 in Combination With Azacitidine in Treatment of Patients With Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is to evaluate safety， tolerability and composite CR of IBI188 plus azacitidine in acute myeloid leukemia

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).

2. Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).

3. Age ≥18 years old, gender not limited.

4. ECOG score of 0-2.

5. Adequate organ function.

Exclusion Criteria:

1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).

2. Prior exposure to any anti-CD47 or anti-SIRPα agents.

3. Major surgery and vaccine treatment within 4 weeks.

4. Uncontrolled concurrent diseases.

5. Pregnant or breastfeeding female subjects.