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TerminatedNCT05148442Updated Sep 8, 2023

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

A Phase 1 interventional study of IBI322 in Myeloid Tumor, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1, Interventional, and Treatment

Why this study was terminated
Due to the company's development strategy adjustment\]
Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Myeloid Tumor
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In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    IBI322

    Drug: IBI322

Interventions

  • DrugIBI322

    Recombinant anti-human CD47/PD-L1 bispecific antibody

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What researchers measure

Primary outcomes

  1. Number of treatment related AEs

    safety and tolerability

    Time frame: Up to 90 days post last dose

Secondary outcomes

  1. Number of patients with response

    preliminary efficacy

    Time frame: Last patient enrolled+24 weeks

07

Study locations

1 site
  • The first affiliated hospital of soochow university
    Suzhou, Jiangsu 215006, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05148442
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Dec 8, 2021
Start date
Dec 28, 2021
Primary completion
Jun 19, 2023
Completion
Aug 29, 2023
Last update
Sep 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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