PD-1 Antibody for Reactive EBV After BMT

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital

Criteria

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.