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.
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
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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Phaeohyphomycosis
- Medical subject headings
- Phaeohyphomycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted28 Jan 2025
- Study start12 Jul 2024
- Primary completion12 Jul 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhaeohyphomycosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Sha, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06796231
- Acronym / sponsor ID
- SYSKY-2024-823-01
- Conditions
- Phaeohyphomycosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 12 Jul 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Severe autoimmune disease; b, serious heart and lung disease, liver and kidney insufficiency; c. Lactating women and pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in CD4 T cells and CD8 T cells
Time frame: through study completion, an average of 1 month
Changes in CD4 T cells and CD8 T cells:through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.