Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Aplastic Anemia

Treatments: Biological: CM313(SC) injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06791824

CM313-124101

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of idiopathic aplastic anemia.
2. Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
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. The inherited bone marrow failure syndromes.
2. Previously treated with the anti-CD38 monoclonal antibody.
3. Have an allergy to humanized monoclonal antibody or any part of CM313.
4. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
5. 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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125 participants in 3 patient groups

CM313(SC)(low dose group)

Experimental group

Treatment:

Biological: CM313(SC) injection

Biological: CM313(SC) injection

Biological: CM313(SC) injection

CM313(SC)(medium dose group)

Experimental group

Treatment:

Biological: CM313(SC) injection

Biological: CM313(SC) injection

Biological: CM313(SC) injection

CM313(SC)(high dose group)

Experimental group

Treatment:

Biological: CM313(SC) injection

Biological: CM313(SC) injection

Biological: CM313(SC) injection