Aplastic AnemiaPhase 1/2NCT06791824
Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
A Phase 1/2 study testing CM313(SC) injection in people with Aplastic Anemia, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- CM313(SC) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of idiopathic aplastic anemia.
- Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
- Male or female, age≥18 years.
- The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
- Willing and able to comply with the requirements for this study and written informed consent.
Who cannot join
- The inherited bone marrow failure syndromes.
- Previously treated with the anti-CD38 monoclonal antibody.
- Have an allergy to humanized monoclonal antibody or any part of CM313.
- Pregnant or breastfeeding females, or females planning to become pregnant during the study.
- Any condition considered to be ineligible for the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Jun Shi
About this study
Official title: A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia
- Conditions
- Aplastic Anemia
- Being tested
- CM313(SC) injection
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313(SC) injectionBiological
Phase IB: CM313(SC) administered at low dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
CM313(SC) injectionBiological
Phase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
CM313(SC) injectionBiological
Phase IB: CM313(SC) administered at high dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
| Study group | Role | What they receive |
|---|---|---|
| CM313(SC)(low dose group) | Experimental | Not described Receives: Biological: CM313(SC) injection |
| CM313(SC)(medium dose group) | Experimental | Not described Receives: Biological: CM313(SC) injection |
| CM313(SC)(high dose group) | Experimental | Not described Receives: Biological: CM313(SC) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
Assess the safety and tolerability
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Shi, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791824
- Sponsor's protocol ID
- CM313-124101
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
- ClinicalTrials.gov ID
- NCT06791824
- Acronym / sponsor ID
- CM313-124101
- Conditions
- Aplastic Anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jan 2025 (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 randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CM313(SC)(low dose group) | Experimental | Biological: CM313(SC) injection |
| CM313(SC)(medium dose group) | Experimental | Biological: CM313(SC) injection |
| CM313(SC)(high dose group) | Experimental | Biological: CM313(SC) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic aplastic anemia.
- Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
- Male or female, age≥18 years.
- The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
- Willing and able to comply with the requirements for this study and written informed consent.
Key exclusion criteria (5 listed)
- The inherited bone marrow failure syndromes.
- Previously treated with the anti-CD38 monoclonal antibody.
- Have an allergy to humanized monoclonal antibody or any part of CM313.
- Pregnant or breastfeeding females, or females planning to become pregnant during the study.
- Any condition considered to be ineligible for the study by the investigator.
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 |
|---|---|---|
| CM313(SC) injectionPhase IB: CM313(SC) administered at low dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results. | Biological | CM313(SC)(low dose group) |
| CM313(SC) injectionPhase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results. | Biological | CM313(SC)(medium dose group) |
| CM313(SC) injectionPhase IB: CM313(SC) administered at high dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results. | Biological | CM313(SC)(high dose group) |
Primary outcome
Adverse events (AE)
Time frame: Up to 52 weeks
Assess the safety and tolerability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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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.
Jun Shi principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM313(SC) injection in people with Aplastic Anemia, run by Keymed Biosciences 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Feb 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) (time frame: Up to 52 weeks). 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 18 Feb 2025.