Mixed Chimerism, PD-1 Antibody
Conditions
Keywords
Chimerism, PD-1
Brief 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.
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.
Interventions
DRUGToripalimab 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.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
one group of HLH patients with mixed chimerism (80%-95%), PD-1 antibody will be used to improve the chimerism
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chimeric rate | 4 weeks after toripalimab injection was used | Chimeric rate in bone marrow or peripheral blood of HLH patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment-related adverse events as assessed by CTCAE v5.0； | every 2 weeks after intervention, until 8 weeks after the use of PD-1 antibody | Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1 year | From enrollment until death or the end of the experiment |
Countries
China
Contacts
Primary ContactZhao Wang
Backup ContactYahong You
Outcome results
None listed