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

ConditionAplastic Anemia

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorKeymed Biosciences Co.Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of idiopathic aplastic anemia.

Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.

Male or female, age≥18 years.

The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.

Disqualifiers

The inherited bone marrow failure syndromes.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

CM313(SC) injection
Biological/Vaccine
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
Biological/Vaccine
Phase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.
CM313(SC) injection
Biological/Vaccine
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.

Treatment groups

125 Participants

are divided into 3 treatment groups

Group A: CM313(SC)(low dose group)Experimental treatment 1 intervention

Group B: CM313(SC)(medium dose group)Experimental treatment 1 intervention

Group C: CM313(SC)(high dose group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse events (AE)

Assess the safety and tolerability

Time frame

Up to 52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: