Platelet Transfusion Refractoriness
Conditions
Brief 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.
Interventions
BIOLOGICALCM313(SC) injection-low dose
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.
BIOLOGICALCM313(SC) injection-high dose
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.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness. 2. Presence of one or more kinds of antiplatelet antibodies. 3. Male or female, age≥18 years. 4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2. 5. Willing and able to comply with the requirements for this study and written informed consent.
Exclusion criteria
1. Diagnosed with Idiopathic thrombocytopenic purpura. 2. Platelet transfusion refractoriness caused by non-immune factors. 3. Previously treated with the anti-CD38 monoclonal antibody. 4. Have an allergy to humanized monoclonal antibody or any part of CM313. 5. Pregnant or breastfeeding females, or females planning to become pregnant during the study. 6. Any condition considered to be ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AE) | Up to 24 weeks | Assess the safety of CM313(SC) injection |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed