PD-1 Antibody for Reactive EBV After BMT

Early Phase 1

• Conditions: Transplant; PD-1; EBV Infection
• Interventions: Drug: toripalimab injection

• Registration Number: NCT04690036
• Lead Sponsor: Beijing Friendship Hospital

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

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-27
• Last Update Posted: 2021-06-29
• Study Start: 2021-07-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China