Myeloid TumorPhase 1NCT05148442
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
A Phase 1 study testing IBI322 in people with Myeloid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Tumor
- What is being tested?
- IBI322
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2021to 29 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
- Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
- Male or female subject above 18 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~ 2.
- Must have adequate organ function
Who cannot join
- Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
- Transformation or treatment related AML/MDS.
- PV/MF/AML/MDS evolved from Essential thrombocythemia
- Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
- Central nervous system leukemia infiltration
- Previous history of chronic hemolytic anemia or screening Coombe test positive
Show all 12Show fewer
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
- Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
- Uncontrolled concurrent diseases
- Subjects who are allergic to the ingredients of the study drug
- Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215006
About this study
Official title: A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
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.
- Conditions
- Myeloid Tumor
- Being tested
- IBI322
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI322Drug
Recombinant anti-human CD47/PD-L1 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| IBI322 | Experimental | Not described Receives: Drug: IBI322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment related AEs
safety and tolerability
Measured: Up to 90 days post last dose
Secondary outcomes (1)
Number of patients with response
preliminary efficacy
Measured: Last patient enrolled+24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start28 Dec 2021
- Primary completion19 Jun 2023
- Study completion29 Aug 2023
Why it stopped: Due to the company's development strategy adjustment\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid TumorStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148442
- Sponsor's protocol ID
- CIBI322A106
- Status last verified
- Sep 2023
- First submitted
- 25 Nov 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor
- ClinicalTrials.gov ID
- NCT05148442
- Acronym / sponsor ID
- CIBI322A106
- Conditions
- Myeloid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment\]
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI322 | Experimental | Drug: IBI322 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
- Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
- Male or female subject above 18 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~ 2.
Key exclusion criteria (12 listed)
- Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
- Transformation or treatment related AML/MDS.
- PV/MF/AML/MDS evolved from Essential thrombocythemia
- Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
- Central nervous system leukemia infiltration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI322Recombinant anti-human CD47/PD-L1 bispecific antibody | Drug | IBI322 |
Primary outcome
Number of treatment related AEs
Time frame: Up to 90 days post last dose
safety and tolerability
1 secondary outcome
Number of patients with response
Time frame: Last patient enrolled+24 weeks
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI322 in people with Myeloid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the company's development strategy adjustment\]). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment related AEs (time frame: Up to 90 days post last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.