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Active, not recruitingNCT06796231Updated Jan 28, 2025

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

An observational study in Phaeohyphomycosis, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Phaeohyphomycosis
03

In context

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Severe autoimmune disease; b, serious heart and lung disease, liver and kidney insufficiency; c. Lactating women and pregnant women.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1 participant (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  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

    Time frame: through study completion, an average of 1 month

07

Study locations

1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    GuangDong, GuangZhou, China
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06796231
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Lu Sha (Principal Investigator(Lu Sha), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jan 28, 2025
Start date
Jul 12, 2024
Primary completion
Jul 12, 2025 (estimated)
Completion
Dec 12, 2025 (estimated)
Last update
Jan 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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