NCT07034209

A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic Characteristics, and Immunogenicity of Plonmarlimab in Subjects With Rheumatic and Immunological Disease-associated Haemophagocytic Lymphohistiocytosis (HLH) (Also Known as Macrophage Activation Syndrome (MAS))

An Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic Characteristics, and Immunogenicity of Plonmarlimab in Subjects With Rheumatic and Immunological Disease-associated Haemophagocytic Lymphohistiocytosis (HLH) (Also Known as Macrophage Activation Syndrome (MAS))

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study adopts an open-label, single-arm, multicenter design to evaluate the efficacy, safety, tolerability, immunogenicity, and PK characteristics of Plonmarlimab administration in patients with rheumatic and immunological disease-associated HLH (MAS), and to explore biomarkers related to the efficacy of Plonmarlimab.

Conditions

• Hemophagocytic Lymphohistiocytoses

Interventions

Type	Name	Description
DRUG	Plonmarlimab	Subjects receive Plonmarlimab 6 mg/kg or 10 mg/kg, administered intravenously, once weekly for 8 weeks.

Timeline

• Start date: 2023-04-07
• Primary completion: 2025-04-18
• Completion: 2025-04-18
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

6 sites across 1 country: China