A Prospective, One-arm and Open Clinical Study of CM313 in the Treatment of Immune Thrombocytopenia

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 22, 2023

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2023

Conditions
Immune ThrombocytopeniaTreatment
Interventions
DRUG

CM313 Injection

"intravenous CM313 administration~This study adopts a prospective, single arm, open design method. Twenty subjects were enrolled in the study and were treated with CD38 monoclonal antibody (CM 313: 16mg/kg/w) for 8 weeks.~The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg CM313 once a week for 8 weeks to observe the safety and efficacy during treatment.~The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of CM313 after treatment."

Trial Locations (1)

300020

Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER