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Active Not Recruiting INTERVENTIONAL NCT03455959

Lung-Resident Memory Th2 Cells in Asthma

Sponsor: Andrew D. Luster, M.D.,Ph.D.

Updated 11 times since 2018 Last updated: Apr 16, 2026 Started: May 23, 2019 Primary completion: Nov 15, 2024 Completion: Dec 15, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Asthma, Allergic, this trial is ongoing. The trial is conducted by Andrew D. Luster, M.D.,Ph.D. and has accumulated 11 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

The objective of this study is to define the mechanisms whereby Th2-Trm persisting in the lung orchestrates a recall response to inhaled allergens. The investigators' central hypothesis is that Th2-Trm ignite allergic airway inflammation via a rapid and enhanced response to cognate antigen in the airway and the ability to recruit circulating Th2 cells (Th2-Tcr) to the sites of antigen presentation in the lung. Mechanistically, the investigators hypothesize that Th2-Trm co-localize with DCs expressing the Th2 cell-attracting chemokine CCL17 and after allergen re-challenge rapidly produce type 2 cytokines that initiate allergic inflammation and markedly enhance DC expression of CCL17. This increased CCL17 expression recruits Th2-Tcr cells from the blood to sites of antigen presentation where Th2-Tcr receive a "second touch" from cognate antigen loaded and activated DCs and become fully competent to amplify allergic inflammation. The investigators propose to use innovative experimental systems to define the function of Th2-Trm, including single cell RNA-seq analysis of human airway mucosal CD4+ T cells obtained via bronchial brushing. Specifically, the investigators propose to define the transcriptional phenotype of human lung Th2-Trm and Th2-Tcr. Defining the mechanisms regulating Th2-Trm function in the asthmatic airway has the potential to yield new therapeutic approaches for allergic...

The objective of this study is to define the mechanisms whereby Th2-Trm persisting in the lung orchestrates a recall response to inhaled allergens. The investigators' central hypothesis is that Th2-Trm ignite allergic airway inflammation via a rapid and enhanced response to cognate antigen in the airway and the ability to recruit circulating Th2 cells (Th2-Tcr) to the sites of antigen presentation in the lung. Mechanistically, the investigators hypothesize that Th2-Trm co-localize with DCs expressing the Th2 cell-attracting chemokine CCL17 and after allergen re-challenge rapidly produce type 2 cytokines that initiate allergic inflammation and markedly enhance DC expression of CCL17. This increased CCL17 expression recruits Th2-Tcr cells from the blood to sites of antigen presentation where Th2-Tcr receive a "second touch" from cognate antigen loaded and activated DCs and become fully competent to amplify allergic inflammation. The investigators propose to use innovative experimental systems to define the function of Th2-Trm, including single cell RNA-seq analysis of human airway mucosal CD4+ T cells obtained via bronchial brushing. Specifically, the investigators propose to define the transcriptional phenotype of human lung Th2-Trm and Th2-Tcr. Defining the mechanisms regulating Th2-Trm function in the asthmatic airway has the potential to yield new therapeutic approaches for allergic asthma. Memory CD4+ T helper type 2 (Th2) cells are critical in promoting allergic asthma, the most common asthma endotype. The investigators propose to define the function of newly described lung-resident memory Th2 cells in driving recurrent allergic airway inflammation. The successful completion of the proposed study has the potential to focus new asthma therapies on specifically targeting the biology of lung-resident memory Th2 cells.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotNot Yet Recruiting~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshotRecruiting~Aug 2019 – ~Nov 2020 · 15 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2022 · 20 months · monthly snapshotRecruiting~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshotRecruiting~Dec 2024 – ~Apr 2026 · 17 months · monthly snapshotActive Not RecruitingApr 18, 2026 – present · 2 months · daily APIActive Not Recruiting

Change History

11 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Active Not Recruiting

    Phase: NANone

  2. Dec 2024 — Apr 2026 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  3. Sep 2024 — Dec 2024 [monthly]

    Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. Sep 2022 — Jul 2024 [monthly]

    Recruiting NA

Show 6 earlier versions
  1. Jan 2021 — Sep 2022 [monthly]

    Recruiting NA

  2. Nov 2020 — Jan 2021 [monthly]

    Recruiting NA

  3. Aug 2019 — Nov 2020 [monthly]

    Recruiting NA

  4. Nov 2018 — Aug 2019 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  5. Jun 2018 — Nov 2018 [monthly]

    Not Yet Recruiting NA

  6. Mar 2018 — Jun 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has the potential to change the therapeutic approach to allergic asthma, the most common asthma subtype. \~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue resident memory cells that are poised to respond upon allergen re-exposure.Consequently, targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is not well understood how allergen inhalation initiates a memory Th2 cell response in the lung. The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating the recall response to allergen in the lung, including the recruitment and activation of circulating Th2 cells, is a natural, timely and exciting extension of the investigators' ongoing Allergen Challenge Protocol.

Contact Information

Sponsor contact:
  • Andrew D. Luster, M.D.,Ph.D.
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations