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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05669638

Collaborator

(none)

Enrollment

Location

21.1

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Immunotherapy ADR

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Autoantibodies [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.
Autoantibodies [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.
Autoantibodies [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.
Autoantibodies [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.
Autoantibodies [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.
the change of immune-related adverse events [baseline to Week 45]
Including polyradiculopathies, neuropathies, myasthenic syndromes, myopathies, hypophysitis, aseptic meningitis, encephalitis, multiple sclerosis and other complications.

Secondary Outcome Measures

the immune cell (Including T cell, B cell, etc.) [Day 1]
Including T cell, B cell, etc. Using flow cytometry
the immune cell (Including T cell, B cell, etc.) [Week 9]
Using flow cytometry
the immune cell (Including T cell, B cell, etc.) [Week 21]
Using flow cytometry
the immune cell (Including T cell, B cell, etc.) [Week 33]
Using flow cytometry
the immune cell (Including T cell, B cell, etc.) [Week 45]
Using flow cytometry
the cytokine [Day 1]
Including IL-6, IL-17, etc.
the cytokine [Week 9]
Including IL-6, IL-17, etc.
the cytokine [Week 21]
Including IL-6, IL-17, etc.
the cytokine [Week 33]
Including IL-6, IL-17, etc.
the cytokine [Week 45]
Including IL-6, IL-17, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years old.
Receiving anti-PD1 immunotherapy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital	Beijing	Beijing	China	100000

Sponsors and Collaborators

Xuanwu Hospital, Beijing

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuanwu Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT05669638

Other Study ID Numbers:

hongyanli1

First Posted:

Jan 3, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Xuanwu Hospital, Beijing

PD1

immunotherapy

Study Results

No Results Posted as of Jan 31, 2023