A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

February 7, 2024 updated by: Xuanwu Hospital, Beijing

The goal of this observational study is to learn about in the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

  • The autoantibody profile of patients
  • The adverse reactions of patients
  • The changes of immune cells and cytokine in patients

Study Overview

Status

Recruiting

Conditions

Detailed Description

The goal of this observational study is to learn about the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

  • The autoantibody profile of patients
  • The adverse reactions of patients
  • The changes of immune cells and cytokine in patients (e.g., T cell, B cell, IL-6, etc.)

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Xuanwu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients receiving anti-PD1 immunotherapy

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Receiving anti-PD1 immunotherapy

Exclusion Criteria:

  1. Vital signs are unstable
  2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autoantibodies
Time Frame: Day 1

Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).

Cell transfection, ELISpot and ELISA are designed to be used.
Day 1
Autoantibodies
Time Frame: Week 9

Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).

Cell transfection, ELISpot and ELISA are designed to be used.
Week 9
Autoantibodies
Time Frame: Week 21

Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).

Cell transfection, ELISpot and ELISA are designed to be used.
Week 21
Autoantibodies
Time Frame: Week 33

Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).

Cell transfection, ELISpot and ELISA are designed to be used.
Week 33
Autoantibodies
Time Frame: Week 45

Including autoantibodies in Autoimmune encephalitis (NMDAR, AMPA1, AMPA2, CASPR2, GABABR, DPPX, IgLON5 and LGI1), myasthenia gravis (Including AChR, MuSK, LRP4, RyR, Titin), paraneoplastic neurologic syndromes (Hu, Yo, Ri, CV2, PNMA2, Amphiphysin, Recoverin, SOX1, Titin, Zic4, GAD65, Tr) and against gangliosides (GM1, GM2, GM3, GM4, GD1a, GD1b, GD2, GD3, GT1a, GT1b, GQ1b, Sulfatides).

Cell transfection, ELISpot and ELISA are designed to be used.
Week 45
the change of immune-related adverse events
Time Frame: baseline to Week 45
Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.
baseline to Week 45

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the immune cell (Including T cell, B cell, etc.)
Time Frame: Day 1
Including T cell, B cell, etc. Using flow cytometry
Day 1
the immune cell (Including T cell, B cell, etc.)
Time Frame: Week 9
Using flow cytometry
Week 9
the immune cell (Including T cell, B cell, etc.)
Time Frame: Week 21
Using flow cytometry
Week 21
the immune cell (Including T cell, B cell, etc.)
Time Frame: Week 33
Using flow cytometry
Week 33
the immune cell (Including T cell, B cell, etc.)
Time Frame: Week 45
Using flow cytometry
Week 45
the cytokine
Time Frame: Day 1
Including IL-6, IL-17, etc.
Day 1
the cytokine
Time Frame: Week 9
Including IL-6, IL-17, etc.
Week 9
the cytokine
Time Frame: Week 21
Including IL-6, IL-17, etc.
Week 21
the cytokine
Time Frame: Week 33
Including IL-6, IL-17, etc.
Week 33
the cytokine
Time Frame: Week 45
Including IL-6, IL-17, etc.
Week 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Hongyan Li, MD,PhD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • hongyanli1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immunotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe