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Study identifier: NCT07714512 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Phase I/II Study of Anti-CD38 Monoclonal Antibody in Refractory Severe Aplastic Anemia

Condition: Aplastic Anemia  ·  Sponsor: Institute of Hematology & Blood Diseases Hospital, China

PhasePhase 1/Phase 2
Planned participants32
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a phase I/II clinical study in adult patients with refractory severe aplastic anemia (SAA). Eligible patients must meet the criteria for refractory SAA and have a platelet count (PLT) \<30 × 10\^9/L and/or hemoglobin (HGB) \<90 g/L at enrollment. If the phase I results demonstrate an acceptable safety profile and allow determination of the maximum tolerated dose (MTD), the phase II part will be initiated directly to evaluate the efficacy of isatuximab.

This description comes directly from the study's public registry record.

Talk to the study team

Lele Zhang, PhD  ·  ‭15811139278‬  ·  zhanglele@ihcams.ac.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Red Blood Cell Diseases Center and Regenerative Medicine CenterTianjin, Tianjin Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07714512