PD-1 Antibody for Reactive EBV After BMT

Capital Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Transplant; PD-1; EBV Infection

Treatments: Drug: toripalimab injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04690036

PD-1,reactive EBV

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

one group

Experimental group

Description:

All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.

Treatment:

Drug: toripalimab injection