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

NCT ID: NCT04795128

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2023-08-15

Brief Summary

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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

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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.

Conditions

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Hematologic Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI322

Single arm

Group Type OTHER

IBI322

Intervention Type BIOLOGICAL

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

Interventions

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IBI322

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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WenBin Qian

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, , China

Site Status

Countries

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China

Other Identifiers

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CIBI322A103

Identifier Type: -

Identifier Source: org_study_id

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