Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 monoclonal antibody group
- description
- 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.
- interventionNames
- Drug: PD-1 monoclonal antibody
Primary outcomes (2)
- measure
- Response rate
- timeFrame
- 3 weeks
- description
- complete response and/or partial response rate
- measure
- EBV-DNA viral load
- timeFrame
- 3 weeks
- description
- EBV-DNA copy by polymerase chain reaction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Meet the diagnostic criteria of EBV-HLH or CAEBV. 2. Newly diagnosed patients. 3. Eastern Cooperative Oncology Group score 0-3. 4. Total bilirubin \<= 10 times of upper limit of normal (except for those caused by EBV-HLH or CAEBV), and serum creatinine \<= 1.5 times of upper limit of normal. 5. Serum HIV antigen or antibody is negative. 6. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV-RNA is negative. 7. Both HbsAg and HbcAb for Hepatitis B virus (HBV) are negative. If not, the quantification of HBV-DNA needs to be \<1\*10e3 IU/ml. 8. The patient or his/her guardian must be able to understand and be willing to participate in this study, and sign the informed consent. Exclusion Criteria: 1. Non EBV-HLH or CAEBV patients. 2. Refractory or relapsed EBV-HLH or CAEBV. 3. Heart function above grade II (NYHA). 4. Patients suffered from other uncontrollable active infections. 5. Pregnant or lactating women. 6. Patients with mental disorders and cannot cooperate with the requirements of research, treatment and monitoring. 7. Active visceral bleeding. 8. Allergic to PD-1 monoclonal antibody. 9. Patients with known autoimmune diseases. 10. Participate in other clinical research at the same time. 11. The investigator judges that the patient has other reasons not suitable for this study, or participating in the study will bring great risks to the patient.
References
Publications (0)
Data not yet available