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

Keymed Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Platelet Transfusion Refractoriness

Treatments: Biological: CM313(SC) injection-high dose; Biological: CM313(SC) injection-low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06792019

CM313-124102

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

CM313(SC)(low dose group)

Experimental group

Treatment:

Biological: CM313(SC) injection-low dose

CM313(SC)(high dose group)

Experimental group

Treatment:

Biological: CM313(SC) injection-high dose