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.
Age: 16 to 80 years (inclusive), of any gender.
The subject is willing to participate in this study and voluntarily signs the informed consent form. For minor subjects aged 16 years (inclusive) to less than 18 years, written informed consent must be signed by both the subject and the subject's legal guardian.
Diagnosed with a rheumatic and immunological disease.
Diagnosed with haemophagocytic lymphohistiocytosis (HLH) according to the HLH-2004 diagnostic criteria (excluding molecular diagnosis)
Confirmed or suspected primary haemophagocytic lymphohistiocytosis (pHLH).
HLH induced by infection (including but not limited to EBV-HLH) or treatment (including but not limited to drugs such as CAR-T cells, TCEs, ADCs).
History of other active neoplasm malignant within 5 years prior to screening, with the exception of successfully treated cutaneous basal cell or squamous cell carcinoma, or localised neoplasms that have been adequately treated with curative intent, including but not limited to, uterine carcinoma in situ, breast cancer in situ, thyroid cancer, etc.; asymptomatic, localised prostate cancer confirmed to have no metastasis and not requiring treatment, etc. Prior to receiving the investigational drug, an assessment by an oncology specialist is required to clarify the current status of the neoplasm malignant and to rule out the possibility of HLH secondary to the neoplasm malignant.
History of allergy to any component of the investigational drug.
Single group
Plonmarlimab
DrugSubjects 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).
Overall response rate (ORR)
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