Platelet Transfusion RefractorinessPhase 1/2NCT06792019
Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
A Phase 1/2 study testing CM313(SC) injection-low dose and CM313(SC) injection-high dose in people with Platelet Transfusion Refractoriness, 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 and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Transfusion Refractoriness
- What is being tested?
- CM313(SC) injection-low dose and CM313(SC) injection-high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 16 Nov 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
- Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
- Presence of one or more kinds of antiplatelet antibodies.
- 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
- Diagnosed with Idiopathic thrombocytopenic purpura.
- Platelet transfusion refractoriness caused by non-immune factors.
- 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, 1 recruiting
- Recruiting
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 and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
This is a randomized, open-label, phase IB/II clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.
- Conditions
- Platelet Transfusion Refractoriness
- Being tested
- CM313(SC) injection-low dose, CM313(SC) injection-high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM313(SC) injection-low doseBiological
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) injection-high doseBiological
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-low dose |
| CM313(SC)(high dose group) | Experimental | Not described Receives: Biological: CM313(SC) injection-high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
Assess the safety of CM313(SC) injection
Measured: Up to 24 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 start25 Mar 2025
- Primary completion16 Nov 2027 (estimated)
- Study completion16 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Transfusion RefractorinessStudies 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
- 110 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
- NCT06792019
- Sponsor's protocol ID
- CM313-124102
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2025
- Last updated
- 15 Aug 2025
- Results posted
- 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 15 Aug 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 and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
- ClinicalTrials.gov ID
- NCT06792019
- Acronym / sponsor ID
- CM313-124102
- Conditions
- Platelet Transfusion Refractoriness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 16 Nov 2027 (estimated)
- Study completion
- 16 Nov 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 and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM313(SC)(low dose group) | Experimental | Biological: CM313(SC) injection-low dose |
| CM313(SC)(high dose group) | Experimental | Biological: CM313(SC) injection-high dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
- Presence of one or more kinds of antiplatelet antibodies.
- 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 (6 listed)
- Diagnosed with Idiopathic thrombocytopenic purpura.
- Platelet transfusion refractoriness caused by non-immune factors.
- 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.
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) injection-low dosePhase 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) injection-high dosePhase 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 24 weeks
Assess the safety of CM313(SC) injection
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 15 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Platelet Transfusion Refractoriness
RecruitingPhase 1
RN1201 Injection in the Treatment of Antibody-Mediated Diseases
Refractory Immune-mediated Platelet Transfusion Refractoriness, Relapsed or Refractory Immune Thrombocytopenia
Not yet recruitingPhase 3
Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies
Hematological Malignancies, Platelet Transfusion Refractoriness (PTR)
RecruitingPhase 2
Rituximab for Serious Aplastic Anemia With Platelet Transfusion Refractoriness
Severe Aplastic Anemia, Platelet Transfusion Refractoriness
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-low dose and CM313(SC) injection-high dose in people with Platelet Transfusion Refractoriness, 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 6 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: looking for participants now, as of the sponsor's last update on 15 Aug 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 24 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 15 Aug 2025.