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PD-1 Antibody for Reactive EBV After BMT

Primary Purpose

PD-1, EBV Infection, Transplant

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
toripalimab injection
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PD-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one group

Arm Description

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

Outcomes

Primary Outcome Measures

EBV-DNA turn negative
after treatment, the EBV-DNA copies can not be detected in peripheral blood

Secondary Outcome Measures

treatment-related adverse events as assessed by CTCAE v5.0
Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on

Full Information

First Posted
December 27, 2020
Last Updated
June 27, 2021
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04690036
Brief Title
PD-1 Antibody for Reactive EBV After BMT
Official Title
Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PD-1, EBV Infection, Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one group
Arm Type
Experimental
Arm Description
All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment.
Intervention Type
Drug
Intervention Name(s)
toripalimab injection
Other Intervention Name(s)
EBV-DNA positive
Intervention Description
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.
Primary Outcome Measure Information:
Title
EBV-DNA turn negative
Description
after treatment, the EBV-DNA copies can not be detected in peripheral blood
Time Frame
4 weeks after PD-1 antibody was used
Secondary Outcome Measure Information:
Title
treatment-related adverse events as assessed by CTCAE v5.0
Description
Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on
Time Frame
4 weeks after PD-1 antibody was used
Other Pre-specified Outcome Measures:
Title
Survival
Description
From enrollment until death or the end of the experiment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Undergo allo-HCT, have achieved full chimerism Age >18 years old, gender is not limited. After transplantation, EBV was reactivated and EBV-DNA was positive in blood No secondary graft failure. (After grafted, ANC <0.5*10^9/l,PLT <10*10^9/l) No uncontrollable infection Withdraw immunosuppressor, no graft-versus-host disease was observed. 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. Informed consent. Exclusion Criteria: Allergic to toripalimab Serious immunoreaction: myocardial damage, hepatitis, pneumonia Central nervous system symptoms Serious mental illness; Active bleeding of the internal organs Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase; Participate in other clinical research at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Wang
Phone
86-010-63139862
Email
wangzhao@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yahong You
Phone
16810283962
Email
15332022659@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Wang
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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PD-1 Antibody for Reactive EBV After BMT

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