A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

NCT ID: NCT05148442

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2023-08-29

Brief Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Detailed Description

Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.

Conditions

Myeloid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI322

Group Type: EXPERIMENTAL

IBI322

Intervention Type: DRUG

Recombinant anti-human CD47/PD-L1 bispecific antibody

Interventions

IBI322

Recombinant anti-human CD47/PD-L1 bispecific antibody

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment.

2. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.

3. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)

4. Male or female subject above 18 years old

5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~ 2.

6. Must have adequate organ function

Exclusion Criteria

1. Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN

2. Transformation or treatment related AML/MDS.

3. PV/MF/AML/MDS evolved from Essential thrombocythemia

4. Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year

5. Central nervous system leukemia infiltration

6. Previous history of chronic hemolytic anemia or screening Coombe test positive

7. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.

8. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)

9. Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose

10. Uncontrolled concurrent diseases

11. Subjects who are allergic to the ingredients of the study drug

12. Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

CIBI322A106

Identifier Type: -

Identifier Source: org_study_id