Clinical trial · Interventional
PD-1 Antibody for Reactive EBV After BMT
Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
NCT04690036CI-TRIAL-00052463unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Conditions
Conditions (3)
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 | — |
| PD-1 | — | UNRESOLVED | — |
| Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| toripalimab injection | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one group
- description
- All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
- interventionNames
- Drug: toripalimab injection
Primary outcomes (1)
- measure
- EBV-DNA turn negative
- timeFrame
- 4 weeks after PD-1 antibody was used
- description
- after treatment, the EBV-DNA copies can not be detected in peripheral blood
Secondary outcomes (1)
- measure
- treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- 4 weeks after PD-1 antibody was used
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.