EBV Infection, PD-1, Transplant
Conditions
Brief summary
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Detailed description
Transplantaion is recongnized as a cure for CAEBV and EBV associated HLH，however, many patients undergo the reactivation of EBV after transpaltion, patiens may at high risk for recurrence of the disease. PD-1 is a promising therapy to solve this problem. The present study was a one-arm clinical study, the main subject is to evaluate the effect of PD-1 antibody on the clearance of EBV
Interventions
DRUGtoripalimab injection
when EBV-DNA is positive after allo-HCT, and EBV infected T/NK cell, one dose of toripalimab 3mg/kg would be used, the same dose would be repeated 4 weeks later.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO criteria. 2. Undergo allo-HCT, have achieved full chimerism 3. Age \>18 years old, gender is not limited. 4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood 5. No secondary graft failure. (After grafted, ANC \<0.5\*10\^9/l,PLT \<10\*10\^9/l) 6. No uncontrollable infection 7. Withdraw immunosuppressor, no graft-versus-host disease was observed. 8. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal. 9. Informed consent.
Exclusion criteria
1. Allergic to toripalimab 2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia 3. Central nervous system symptoms 4. Serious mental illness; 5. Active bleeding of the internal organs 6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase; 7. Participate in other clinical research at the same time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EBV-DNA turn negative | 4 weeks after PD-1 antibody was used | after treatment, the EBV-DNA copies can not be detected in peripheral blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment-related adverse events as assessed by CTCAE v5.0 | 4 weeks after PD-1 antibody was used | Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1 year | From enrollment until death or the end of the experiment |
Countries
China
Contacts
Primary ContactZhao Wang
Backup ContactYahong You
Outcome results
None listed