PD-1 Antibody for Reactive EBV After BMT

Transplant Clinical Trial

Official title:

Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04690036
• Other study ID #: PD-1,reactive EBV
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2021
• Source: Beijing Friendship Hospital
• Contact: Zhao Wang
• Phone: 86-010-63139862
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• EBV Infection
• Epstein-Barr Virus Infections
• PD-1
• Transplant

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survival	From enrollment until death or the end of the experiment	1 year
Primary	EBV-DNA turn negative	after treatment, the EBV-DNA copies can not be detected in peripheral blood	4 weeks after PD-1 antibody was used
Secondary	treatment-related adverse events as assessed by CTCAE v5.0	Adverse events including thyroid function,liver function damage, myelosuppression, infection, bleeding and so on	4 weeks after PD-1 antibody was used