A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Inclusion criteria

• Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment
• At least one evaluable lesion
• Male or female 18 to 75 years old
• Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2
• Must have adequate organ function

Exclusion criteria

• Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein
• Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
• Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
• Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start
• A history of blood transfusion within 2 weeks prior to study start