PD-1 Antibody for Reactive EBV After BMT

NCT ID: NCT04690036

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-01-01

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

Conditions

PD-1; EBV Infection; Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

one group

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

Group Type: EXPERIMENTAL

toripalimab injection

Intervention Type: DRUG

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.

Interventions

toripalimab 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.

Intervention Type: DRUG

Other Intervention Names

EBV-DNA positive

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Department of Hematology, Beijing Friendship Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhao Wang

Role: CONTACT

wangzhao@ccmu.edu.cn

86-010-63139862

Yahong You

Role: CONTACT

15332022659@163.com

16810283962

Other Identifiers

PD-1,reactive EBV

Identifier Type: -

Identifier Source: org_study_id