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PhaeohyphomycosisNCT06796231

Efficacy of PD-1 Monoclonal Antibody in the Treatment of Phaeohyphomycosis

An observational study of Phaeohyphomycosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main objective was to evaluate the clinical efficacy of PD-1 inhibitor (PD-1 monoclonal antibody) in the treatment of skin and subcutaneous mucocytosis infection, including the comparison of immune cell groups before and after treatment, the changes in the proportion of CD4+T cells and CD8+T cells, and the changes… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Phaeohyphomycosis
How many people
1 participants
Where
1 siteChina
Study dates
12 Jul 2024to 12 Dec 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 1. Fungal infection of skin and subcutaneous tissue; 2. the conventional treatment effect is not good; 3. immunodeficient host; d. PD-1 has been used or is intended to be used for treatment

Who may be able to join

  • A. Fungal infection of skin and subcutaneous tissue; b, the conventional treatment effect is not good; c, immunodeficient host; d. PD-1 has been used or is intended to be used for treatment

Who cannot join

  • Severe autoimmune disease; b, serious heart and lung disease, liver and kidney insufficiency; c. Lactating women and pregnant women.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangdong, GuangZhou

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Prognosis of PD-1 Monoclonal Antibody in the Treatment of the Skin and Subcutaneous Tissue Phaeohyphomycosis of Immunodeficient Patients

The main objective was to evaluate the clinical efficacy of PD-1 inhibitor (PD-1 monoclonal antibody) in the treatment of skin and subcutaneous mucocytosis infection, including the comparison of immune cell groups before and after treatment, the changes in the proportion of CD4+T cells and CD8+T cells, and the changes in the inflammatory cytokines of the serum after co-culture of human peripheral blood mononuclear cells (PBMC) with fungi before and after treatment. The improvement of lesions and the relief of symptoms. The secondary objective is to evaluate the safety of PD-1 inhibitors during treatment, including monitoring and recording all adverse events and immune-related adverse reactions.

Read the detailed description

The primary objective of this study was to evaluate the clinical efficacy of PD-1 inhibitors (PD-1 monoclonal antibodies) in the treatment of skin and subcutaneous mucocytosis infections. This included comparing immune cell groups before and after treatment, observing changes in the proportion of CD4+ T cells and CD8+ T cells, and monitoring alterations in serum inflammatory cytokines following co-culture of human peripheral blood mononuclear cells (PBMCs) with fungi before and after treatment. Additionally, the study assessed the improvement of lesions and the relief of symptoms. The secondary objective was to evaluate the safety of PD-1 inhibitors during treatment, which involved monitoring and recording all adverse events and immune-related adverse reactions.

The study confirmed that the expression of co-inhibitory molecules is upregulated in exhausted T cells following chronic infection. Blocking the expression of these co-inhibitory molecules may be significant in the treatment of such diseases, providing potential theoretical support for understanding the underlying mechanisms and developing subsequent new therapeutic approaches.

Integrating the above information, we can conclude the following:

  1. Clinical Efficacy Assessment: By comparing immune cell groups, T cell subsets, and serum inflammatory cytokines before and after treatment with PD-1 inhibitors, the study aimed to evaluate the effectiveness of PD-1 inhibitors in the treatment of skin and subcutaneous infections, as well as observing improvements in lesions and symptom relief.
  2. Safety Assessment: Monitoring and recording all adverse events and immune-related adverse reactions during the treatment period to assess the safety of PD-1 inhibitors.
  3. Immune Mechanism Exploration: The study found that the expression of co-inhibitory molecules is upregulated in exhausted T cells following chronic infection, indicating that blocking the expression of these molecules may play a positive role in treating such diseases, offering a new perspective for future treatment strategies.
  4. Theoretical Support: The results of this study provide a theoretical basis for understanding the immune mechanisms of chronic infections and potential support for developing new therapeutic approaches, which is significant for improving patient outcomes and developing new therapies.

In summary, the study not only assessed the efficacy and safety of PD-1 inhibitors but also provided valuable information for深入 understanding the immune mechanisms of chronic infections and developing new treatment strategies.

Medical subject headings
Phaeohyphomycosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in CD4 T cells and CD8 T cells

    Changes in CD4 T cells and CD8 T cells:through study completion, an average of 1 month

    Measured: through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start12 Jul 2024
  3. Primary completion12 Jul 2025 (estimated)
  4. Study completion12 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06796231
Sponsor's protocol ID
SYSKY-2024-823-01
Status last verified
Jan 2025
First submitted
16 Nov 2024
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Phaeohyphomycosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in CD4 T cells and CD8 T cells (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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