NCT07208058View on ClinicalTrials.gov

A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 20, 2026

Study Completion Date

November 30, 2027

Conditions
Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis
Interventions
DRUG

Plonmarlimab

Subjects will receive Plonmarlimab 10 mg/kg by intravenous injection once weekly from Week 1 to Week 3, and Plonmarlimab 6 mg/kg by intravenous injection once weekly from Week 4 to Week 8 (10 mg/kg QW×3 + 6 mg/kg QW×5).

Trial Locations (15)

Unknown

Beijing Friendship Hospital, Capital Medical University, Beijing

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing

Peking University People's Hospital, Beijing

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

The Second Hospital of Hebei Medical University, Shijiazhuang

Children's Hospital of Zhengzhou University, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

The First Affiliated Hospital of Nanchang University, Nanchang

The First Affiliated Hospital of China Medical University, Shenyang

Children's Hospital of Fudan University, Shanghai

Huashan Hospital, Fudan University, Shanghai

Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

Tianjin Medical University General Hospital, Tianjin

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

TJ Biopharma Co., Ltd.

INDUSTRY