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

Myeloid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05148442
• Other study ID #: CIBI322A106
• Status: Terminated
• Phase: Phase 1
• Start date: December 28, 2021
• Est. completion date: August 29, 2023

Study information

• Verified date: September 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 29, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, SIRPa antibody, or CD47/SIRPa 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

Related Conditions & MeSH terms

• Myeloid Tumor

Intervention

Drug:
• IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody

Locations

Country	Name	City	State
China	The first affiliated hospital of soochow university	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment related AEs	safety and tolerability	Up to 90 days post last dose
Secondary	Number of patients with response	preliminary efficacy	Last patient enrolled+24 weeks