Immune monitoring during invasive mold infections.
Immunomonitoring of Mold Invasive Infections
This project will test whether tracking T-cell immune checkpoints can identify adults with invasive mold infections who might benefit from adding immunotherapy to antifungal treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT06285188 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal observational project that follows adults with proven or probable invasive mold infections (Aspergillus, Mucorales, Fusarium, Scedosporium) to characterize adaptive immune responses over time. Investigators will measure immune checkpoint expression on T cells (for example PD‑1 and CTLA‑4), perform functional assays such as ELISPOT for selected patients, and correlate immune markers with clinical course and antifungal response. Patients are eligible if enrolled within 14 days of diagnosis or if they have refractory disease requiring a change in antifungal therapy, and selected assays require a minimum lymphocyte count. No experimental treatments are assigned; standard antifungal care continues while samples are collected to identify signals that could guide adjunct immunotherapy timing.
Who should consider this trial
Good fit: Adults (≥18) with proven or probable invasive mold infections (Aspergillus, Mucorales, Fusarium, Scedosporium) enrolled within 14 days of diagnosis or with documented refractory disease, who meet lab criteria for specific assays (for example total lymphocytes >700/mm3 for ELISPOT) and have not previously received anti‑PD1 therapy.
Not a fit: Patients with recent bacterial co‑infection, prior anti‑PD1 treatment, severe lymphopenia that precludes immune testing, or those unable to attend the Paris site are unlikely to benefit from or be eligible for this monitoring approach.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify which patients with invasive mold infections might benefit from adding immune checkpoint–targeted immunotherapy and determine the best timing for such treatment.
How similar studies have performed: A few case reports and animal studies suggest immune checkpoint blockade can help in severe fungal infections and prior cytokine (IFNγ) adjuncts showed partial success, but robust clinical evidence for checkpoint blockade in invasive fungal disease is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Mold invasive fungal infection: Aspergillus, Mucorales, Fusarium, Scedosporium * Proven or probable according to 2019 EORTC/MGS criteria modified by the adjunction of diabetes mellitus in the host criteria and Mucorales PCR in the microbiological criteria * Within 14 days of IFD diagnosis or * a refractory state defined by the 2009 MGS/EORT failure criteria (clinical, radiological, or microbiological failure) of a first-line antifungal treatment leading to a change of therapy by the attending physician of the patient * Patients with aspergillosis or mucormycosis for whom ELISPOTs are developed: Total lymphocyte count \> 700/mm3 on the last sample taken * No opposition to participate to the research * Affiliated or beneficiary of social security system Exclusion Criteria: * Bacterial co-infection in the last 14 days * Previous treatment with anti-PD1 antibodies
Where this trial is running
Paris
- Hôpital Necker Enfants Malades — Paris, France (Recruiting)
Study contacts
- Study coordinator: Alexandra SERRIS, MD, PhD
- Email: alexandra.serris@aphp.fr
- Phone: 06 68 80 24 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.