PD-1 Antibody Improve Mixed Chimerism

PD-1 Antibody Clinical Trial

— HLH  

Official title:

PD-1 Antibody Improve Mixed Chimerism in Patients With Hemophagocytic Lymphohistiocytosis After Allo-HCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04944511
• Other study ID #: PD-1, mixed chimerism
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: May 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/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.

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.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

1. EBV-HLH according to the HLH-04 diagnostic criteria.

2. After allo-HCT, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism.

3. Withdraw immunosuppressive agent, chimeric rate was 80%-95%

4. Age >18 years old, gender is not limited.

5. no graft-versus-host disease was observed.

6. No secondary graft failure (ANC <0.5*10^9/l,PLT <10*10^9/l)

7. 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.

8. Informed consent.

Exclusion Criteria:

1. Allergic to the test drug ingredients or to a more severe allergic constitution.

2. Chimeric rate continue to decline after 2 weeks of toripalimab Injection used.

3. Serious immunoreaction: myocardial damage, hepatitis, pneumonia.

4. Central nervous system symptoms.

5. Serious mental illness.

6. Active bleeding of the internal organs

7. Uncontrollable infection;

8. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;

9. Participate in other clinical research at the same time.

Related Conditions & MeSH terms

• PD-1 Antibody

Intervention

Drug:
• Toripalimab Injection
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.

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	Chimeric rate	Chimeric rate in bone marrow or peripheral blood of HLH patients	4 weeks after toripalimab injection 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.	every 2 weeks after intervention, until 8 weeks after the use of PD-1 antibody