Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

Launched by KEYMED BIOSCIENCES CO.LTD · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment, called CM313(SC) injection, for people who have difficulty receiving platelet transfusions due to a condition known as platelet transfusion refractoriness. This means that even after receiving platelet donations, their blood doesn’t respond as it should, which can lead to serious health issues. The trial is in its early stages and aims to find out if this new treatment is safe and if it works well for patients experiencing this problem.

To participate in the study, you need to be an adult (18 years or older) who has a low platelet count and has been diagnosed with platelet transfusion refractoriness, meaning you have specific antibodies against platelets. Participants will be closely monitored throughout the trial to ensure their safety and to gather information on how well the treatment works. It's important to note that certain conditions, like specific blood disorders or allergies, may prevent someone from joining the study. This trial is not yet recruiting participants, but it holds promise for improving treatment options for those with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.