Actively Recruiting
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])
Led by TJ Biopharma Co., Ltd. · Updated on 2025-12-02
30
Participants Needed
15
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study designed to evaluate the efficacy, safety, immunogenicity, PK, and PD characteristics of Plonmarlimab in patients with relapsed/refractory rheumatic and immunologic disease-associated MAS, and to explore biomarkers related to the efficacy of Plonmarlimab.
CONDITIONS
Official Title
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])
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 80 years, any gender
- Willing to participate and able to sign informed consent (legal guardian consent required for minors aged 16 to under 18)
- Diagnosed with a rheumatic or immunologic disease
- Diagnosed with haemophagocytic lymphohistiocytosis (HLH) using HLH-2004 diagnostic criteria (excluding molecular diagnosis)
- No response to, dependence on, intolerance to, or worsening during high-dose corticosteroid therapy (at least 1.5-2.0 mg/kg/day prednisone or equivalent for 3 consecutive days, including methylprednisolone pulse therapy)
You will not qualify if you...
- Confirmed or suspected primary haemophagocytic lymphohistiocytosis (pHLH)
- HLH caused by infection or treatment (including EBV-HLH, CAR-T cells, TCEs, ADCs)
- History of active malignant neoplasm within 5 years prior to screening, except certain treated localized cancers
- Allergy to any component of the investigational drug
- Lung disorders significantly affecting pulmonary function or abnormal lung function tests
- Recent severe cardiovascular events or severe heart disease (NYHA class III-IV)
- Uncontrolled infections during screening (including tuberculosis, active syphilis, viral infections, and bacterial infections)
- Abnormal kidney function (elevated creatinine or urea, or low eGFR below 60 mL/min)
- Past or current hematological diseases such as myelofibrosis, aplastic anemia, leukemia, lymphoma
- Planned surgery or medical conditions making participation unsuitable
- History of major organ or stem cell transplants
- Clinically significant unstable or uncontrolled acute or chronic diseases
- Pregnant or lactating women
- Participation in other clinical trials or use of invasive investigational devices within 3 months prior to enrollment
- Receipt of live vaccine within 30 days prior to screening
- Evidence of alcohol abuse within 3 months prior to screening or current abuse
- Other conditions judged by the investigator to make participation unsafe or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
4
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
5
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
6
Children's Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
9
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
10
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
11
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
12
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
13
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
14
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
15
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
B
Biwei Zeng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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