drugset

drugset / Trial / NCT06199089

A Randomized, Double-blind, Placebo-controlled, and Multi-center Clinical Study of CM313 in the Treatment of Immune Thrombocytopenia

NCT06199089 ↗

Phase 2 Active not recruiting 45 enrolled Institute of Hematology & Blood Diseases Hospital, China Henan Cancer Hospital · collab North China University of Science and Technology · collab The Second Affiliated Hospital of Kunming Medical University · collab Tianjin Medical University Second Hospital · collab Tianjin People's Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and safety of CM313 in the treatment of immune thrombocytopenia in patients who have failed glucocorticoid therapy.

Timeline

Start: 2024-01-16
Primary completion: 2024-11-28
Completion: 2024-12

Publications

Chen Y, Xu Y, Dai J, Sun T, Li H, Hua Z, Zhou Z, Zhou H, Yan Z, Zhao X, Xue F, Liu W, Liu X, Fu R, Wang W, Chi Y, Dong H, Ju M, Dai X, Gu W, Pei X, Yang R, Zhang L. Anti-CD38 monoclonal antibody CM313 for primary immune thrombocytopenia: multicentre, randomised, placebo controlled, phase 2 trial. BMJ. 2025 Oct 21;391:e084314. doi: 10.1136/bmj-2025-084314.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LUMROTATUG	Monoclonal antibody	16 mg/kg	Intravenous

Indications