Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease (CYTILDASS)

Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.

Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.

The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.

Study Overview

• Status: Recruiting
• Conditions: Antisynthetase Syndrome
• Intervention / Treatment: Diagnostic test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Paul DECKER, MD; Phone Number: +33383157240; Email: p.decker@chru-nancy.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • Bernard Bonnotte
    • Contact: Bernard Bonnotte, PhD
  • Metz, France
    • Recruiting
    • Julien Campagne
    • Contact: Julien Campagne, MD
  • Nancy, France
    • Recruiting
    • Paul Decker
    • Contact: Paul Decker; Phone Number: +33383157240; Email: p.decker@chru-nancy.fr
  • Paris, France
    • Not yet recruiting
    • Olivier Benveniste
    • Contact: Oivier Benveniste, PhD
  • Reims, France
    • Recruiting
    • Loïs Bolko
    • Contact: Loïs Bolko, MD
  • Strasbourg, France
    • Recruiting
    • Alain Meyer
    • Contact: Alain Meyer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with AS and ILD

Description

Inclusion Criteria:

• Patient with new diagnosis of AS with ILD

Exclusion Criteria:

• Patient with ILD differential diagnosis
• Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AS patients with ILD; New diagnosis of patients with AS syndrome and ILD	Diagnostic test: BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT; BAL antigen-specific Th1 cells and Th17 cells, ILC and MAIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BAL antigen-specific Th1 and Th17 cells	BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells	baseline (J0)
FVC relative change	Relative change of FVC percentage	within 6 months after diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BAL antigen-specific Th1 and Th17 cells	BAL antigen-specific Th1 and Th17 cells percentages among total BAL CD4+ T cells	baseline (J0)
FVC	FVC percentage at ILD diagnosis	baseline (J0)
FVC absolute change	Absolute change of FVC percentage	within 6 months after diagnosis
Global activity	MDAAT score	baseline (J0)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BAL ILC	BAL ILC percentage among total BAL lymphoid cells	baseline (J0)
BAL MAIT	BAL MAIT percentage among total BAL T cells	baseline (J0)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Paul Decker, MD, CHU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Lung Diseases; Myositis; Lung Diseases, Interstitial
• Other Study ID Numbers: 2023-A00804-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No