PD-1 Antibody for Reactive EBV After BMT | NCT04690036

Studies
PD-1 Antibody for Reactive EBV After BMT

NCT04690036

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Jun 29, 2021Actual

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

PD-1
EBV Infection
Transplant

Interventions

toripalimab injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Estimated

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Dec 27, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2021

Last Update Posted Date

Jun 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
toripalimab injection	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
Survival	From enrollment until death or the end of the experiment	1 year

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhao Wang	Contact	86-010-63139862		wangzhao@ccmu.edu.cn
Yahong You	Contact	16810283962		15332022659@163.com

Overall Officials

Name	Affiliation	Role
Zhao Wang	Beijing Friendship Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital, Capital Medical University		Beijing	Beijing Municipality	100050	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections