Status:
COMPLETED
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04795128
Start Date
May 7 2021
End Date
August 15 2023
Last Update
November 6 2024
Active Locations (1)
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1
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, China