PD-1 Antibody Improve Mixed Chimerism

NCT04944511 | Unknown

• 1 other identifier: PD-1, mixed chimerism
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 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.

Conditions

PD-1 Antibody; Mixed Chimerism

Keywords

Chimerism; PD-1

Outcome Measures

Primary Outcomes (1)

• Chimeric rate

  Chimeric rate in bone marrow or peripheral blood of HLH patients

  4 weeks after toripalimab injection was used

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Survival

  1 year

Study Arms (1)

PD-1 antibody for mixed chimerism

EXPERIMENTAL

PD-1 antibody (Toripalimab Injection) used for mixed chimerism in HLH patients after allo-HCT

Drug: Toripalimab Injection

Interventions

Toripalimab Injection DRUG

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.

PD-1 antibody for mixed chimerism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• Zhao Wang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang

CONTACT

86-010-63139862; wangzhao@ccmu.edu.cn

Yahong You

CONTACT

17810283962; 15332022659@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: one group of HLH patients with mixed chimerism (80%-95%), PD-1 antibody will be used to improve the chimerism

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: June 29, 2021
• Study Start: July 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)