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

NCT06791824 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-02-18

No results posted yet for this study

Summary

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

Conditions

  • Aplastic Anemia

Interventions

BIOLOGICAL

CM313(SC) injection

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.

BIOLOGICAL

CM313(SC) injection

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.

BIOLOGICAL

CM313(SC) injection

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 & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Jun Shi · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791824 on ClinicalTrials.gov