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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04795128

Enrollment

Registered

2021-03-12

Start date

2021-05-07

Completion date

2023-08-15

Last updated

2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy

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 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.

Interventions

BIOLOGICALIBI322

Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment 2. At least one evaluable lesion 3. Male or female 18 to 75 years old 4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2 5. Must have adequate organ function

Exclusion criteria

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein 2. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) 3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies 4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start 5. A history of blood transfusion within 2 weeks prior to study start

Design outcomes

Primary

Measure	Time frame	Description
Number of treatment related AEs	Up to 90 days post last dose	Safety
Number of patients with response	Last patient enrolled +24 weeks	Preliminary Efficacy

Secondary

Measure	Time frame	Description
PK Parameters: Half-life (t1/2)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Clearance (CL)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: The area under the curve (AUC)	Up to 90 days post last dose	Safety and Preliminary Efficacy
Positive Rate of ADA and Nab	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Volume of Distribution (V)	Up to 90 days post last dose	Safety and Preliminary Efficacy
PK Parameters: Maximum concentration (Cmax)	Up to 90 days post last dose	Safety and Preliminary Efficacy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026