PD-1Early Phase 1NCT04690036
PD-1 Antibody for Reactive EBV After BMT
A Early Phase 1 study testing toripalimab injection in people with PD-1 and EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD-1, EBV Infection, Transplant
- What is being tested?
- toripalimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jan 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Read the 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
- Being tested
- toripalimab injection
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toripalimab injectionDrug
Also called EBV-DNA positive
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.
| Study group | Role | What they receive |
|---|---|---|
| one group | Experimental | All patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment. Receives: Drug: toripalimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBV-DNA turn negative
after treatment, the EBV-DNA copies can not be detected in peripheral blood
Measured: 4 weeks after PD-1 antibody was used
Secondary outcomes (1)
treatment-related adverse events as assessed by CTCAE v5.0
Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on
Measured: 4 weeks after PD-1 antibody was used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
- Investigators
- Zhao Wang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690036
- Sponsor's protocol ID
- PD-1,reactive EBV
- Status last verified
- Jun 2021
- First submitted
- 27 Dec 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
- ClinicalTrials.gov ID
- NCT04690036
- Acronym / sponsor ID
- PD-1,reactive EBV
- Conditions
- PD-1, EBV Infection, Transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | Experimental | Drug: toripalimab injectionAll patients encountered EBV reactivation after allo-HCT could be enrolled in this study, there was only one group of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- Allergic to toripalimab
- Serious immunoreaction: myocardial damage, hepatitis, pneumonia
- Central nervous system symptoms
- Serious mental illness;
- Active bleeding of the internal organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toripalimab injectionAlso: EBV-DNA positivewhen 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. | Drug | one group |
Primary outcome
EBV-DNA turn negative
Time frame: 4 weeks after PD-1 antibody was used
after treatment, the EBV-DNA copies can not be detected in peripheral blood
1 secondary outcome
treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 4 weeks after PD-1 antibody was used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Wang principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing toripalimab injection in people with PD-1 and EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wang (86-010-63139862, wangzhao@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBV-DNA turn negative (time frame: 4 weeks after PD-1 antibody was used). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.