PD-1 Antibody Improve Mixed Chimerism (HLH)

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Capital Medical University

Status

Unknown

Conditions

Mixed Chimerism
PD-1 Antibody

Treatments

Drug: Toripalimab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04944511
PD-1, mixed chimerism

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

PD-1 antibody for mixed chimerism
Experimental group
Description:
PD-1 antibody (Toripalimab Injection) used for mixed chimerism in HLH patients after allo-HCT
Treatment:
Drug: Toripalimab Injection

Trial contacts and locations

1

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Central trial contact

Zhao Wang; Yahong You

Data sourced from clinicaltrials.gov

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