NCT05039580

Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy

A Clinical Trial of PD-1 Monoclonal Antibody as First-line Induction Therapy for EBV-associated Hemophagocytic Syndrome (EBV-HLH) or Chronic Active EBV Infection (CAEBV)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

EBV-HLH and CAEBV are both caused by EBV infection, part of them can rapidly lead to a syndrome of severe, life-threatening hyper-inflammation, with poor prognosis. Currently, the most effective treatment remains unknown. This study is trying to evaluate the efficacy and safety of PD-1 monoclonal antibody as a first-line therapy for EBV-HLH and CAEBV.

Detailed description

Eligible patients who were diagnosed with EBV-HLH or CAEBV, age between 12 and 70 years, were enrolled in this study. All of them need to sign the informed consent first. PD-1 monoclonal antibody 200mg is infused intravenously once for patients whose age \>=18 years, or age \<18 years but weight \>=40kg. While for patients age \<18 years, the dose of PD-1 monoclonal antibody is 3mg/kg. Besides, optimal supportive care is necessary. Ruxolitinib and/or low-dose glucocorticoid can be used to reduce inflammation. Cerebrospinal fluid parameters are examined, and methotrexate 15mg combined with dexamethasone will be intrathecal injected without contraindications. Clinical and laboratory indicators are investigated weekly to evaluate the efficacy and toxicity. If patients achieve partial response/complete response within 14 days after PD-1 monoclonal antibody, the clinical observations are stopped. If not, the observation period is prolonged to 21 days. If disease progress at day 21, this study is terminated, and the patient should be transfer to other treatments as soon as quickly.

Conditions

• EBV Infection

Interventions

Type	Name	Description
DRUG	PD-1 monoclonal antibody	PD-1 monoclonal antibody is a new attempt treatment, and ruxolitinib and/or low-dose dexamethasone can reduce the inflammation that occur in EBV-HLH or CAEBV.

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2021-09-09
• Last updated: 2021-09-09

Locations

1 site across 1 country: China