PD-1 AntibodyHLHNCT04944511
PD-1 Antibody Improve Mixed Chimerism
A study testing Toripalimab Injection in people with PD-1 Antibody and Mixed Chimerism, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
PD-1/PD-L1 pathway play an important role in Inhibiting the function of antigen-specific CD8+T cells, thus matter a lot in immune escape. We intend to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-HCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD-1 Antibody, Mixed Chimerism
- 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 May 2023
- Phase
- Interventional
- 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
- EBV-HLH according to the HLH-04 diagnostic criteria.
- After allo-HCT, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism.
- Withdraw immunosuppressive agent, chimeric rate was 80%-95%
- Age >18 years old, gender is not limited.
- no graft-versus-host disease was observed.
- No secondary graft failure (ANC <0.5*10^9/l,PLT <10*10^9/l)
- 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 the test drug ingredients or to a more severe allergic constitution.
- Chimeric rate continue to decline after 2 weeks of toripalimab Injection used.
- Serious immunoreaction: myocardial damage, hepatitis, pneumonia.
- Central nervous system symptoms.
- Serious mental illness.
- Active bleeding of the internal organs
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- Uncontrollable infection；
- 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: PD-1 Antibody Improve Mixed Chimerism in Patients With Hemophagocytic Lymphohistiocytosis After Allo-HCT
PD-1/PD-L1 pathway play an important role in Inhibiting the function of antigen-specific CD8+T cells, thus matter a lot in immune escape. We intend to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-HCT.
Read the detailed description
Mixed chimerism is a trouble condition after allogeneic hematopoietic cell transplantation (Allo-HCT),all targeted treatment are aimed to improve the function of lymphocyte recipient. PD-1 antibody was reported to restored the function of impaired lymphocyte. Therefore, we want to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in HLH patients after allo-HCT.
- Conditions
- PD-1 Antibody, Mixed Chimerism
- Being tested
- Toripalimab Injection
- Keywords
- Chimerism, PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab InjectionDrug
Toripalimab Injection used for mixed chimerism between 80%-95% in HLH patients. Dose: 240mg toripalimab Injection, two weeks later, the same dose will be repeated if patients have some improve in the chimeric rate.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody for mixed chimerism | Experimental | PD-1 antibody (Toripalimab Injection) used for mixed chimerism in HLH patients after allo-HCT Receives: Drug: Toripalimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chimeric rate
Chimeric rate in bone marrow or peripheral blood of HLH patients
Measured: 4 weeks after toripalimab injection 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: every 2 weeks after intervention, until 8 weeks after the use of PD-1 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1 AntibodyStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one group of HLH patients with mixed chimerism (80%-95%), PD-1 antibody will be used to improve the chimerism
- 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, Capital Medical University
- Investigators
- Zhao Wang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944511
- Sponsor's protocol ID
- PD-1, mixed chimerism
- Acronym
- HLH
- 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
- PD-1 Antibody Improve Mixed Chimerism in Patients With Hemophagocytic Lymphohistiocytosis After Allo-HCT
- ClinicalTrials.gov ID
- NCT04944511
- Acronym / sponsor ID
- HLH / PD-1, mixed chimerism
- Conditions
- PD-1 Antibody, Mixed Chimerism
- Keywords
- Chimerism, PD-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
- Jan 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 29 Jun 2021 (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/PD-L1 pathway play an important role in Inhibiting the function of antigen-specific CD8+T cells, thus matter a lot in immune escape. We intend to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-HCT.
Detailed description
Mixed chimerism is a trouble condition after allogeneic hematopoietic cell transplantation (Allo-HCT),all targeted treatment are aimed to improve the function of lymphocyte recipient. PD-1 antibody was reported to restored the function of impaired lymphocyte. Therefore, we want to use PD-1 antibody to improve the function of lymhocyte and improve the chimerism in HLH patients after allo-HCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group of HLH patients with mixed chimerism (80%-95%), PD-1 antibody will be used to improve the chimerism
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody for mixed chimerism | Experimental | Drug: Toripalimab InjectionPD-1 antibody (Toripalimab Injection) used for mixed chimerism in HLH patients after allo-HCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- EBV-HLH according to the HLH-04 diagnostic criteria.
- After allo-HCT, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism.
- Withdraw immunosuppressive agent, chimeric rate was 80%-95%
- Age >18 years old, gender is not limited.
- no graft-versus-host disease was observed.
Key exclusion criteria (9 listed)
- Allergic to the test drug ingredients or to a more severe allergic constitution.
- Chimeric rate continue to decline after 2 weeks of toripalimab Injection used.
- Serious immunoreaction: myocardial damage, hepatitis, pneumonia.
- Central nervous system symptoms.
- Serious mental illness.
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 InjectionToripalimab Injection used for mixed chimerism between 80%-95% in HLH patients. Dose: 240mg toripalimab Injection, two weeks later, the same dose will be repeated if patients have some improve in the chimeric rate. | Drug | PD-1 antibody for mixed chimerism |
Primary outcome
Chimeric rate
Time frame: 4 weeks after toripalimab injection was used
Chimeric rate in bone marrow or peripheral blood of HLH patients
1 secondary outcome
treatment-related adverse events as assessed by CTCAE v5.0；
Time frame: every 2 weeks after intervention, until 8 weeks after the use of PD-1 antibody
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 study testing Toripalimab Injection in people with PD-1 Antibody and Mixed Chimerism, 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 8 inclusion and 9 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.
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?
Chimeric rate (time frame: 4 weeks after toripalimab injection 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.