Cord blood cells engineered to fight deadly mold in first human test
NCT ID NCT07454122
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new approach for patients with invasive mold infections that are not responding to standard antifungal medicines. Researchers take natural killer (NK) cells from donated umbilical cord blood and genetically modify them to better target the mold. The study will enroll 10 adults to see if the treatment is safe and tolerable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified natural killer (NK) cells from umbilical cord blood
- What this could lead to
- If it works, this could offer a new treatment option for people with severe mold infections that don't respond to standard antifungal drugs.
- What could go wrong
- This is a very early, small phase 1 trial with only 10 participants, so it's mainly checking safety. It may not work, and there could be serious side effects from the cell infusion.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years. 2. Diagnosis of probable or proven fungal infection according to EORTC criteria20, who have been treated with the best available antifungal strategy and present at least one of the following criteria indicating inadequate response to antifungal therapy: Increase in fungal infection biomarker levels (serum or bronchoalveolar lavage galactomannan, or serum β-D-glucan) after at least one week of antifungal therapy: 1. Persistence of positive cultures despite having received ≥2 weeks of appropriate antifungal treatment. 2. Radiological worsening of lesions suggestive of fungal infection despite having received ≥2 weeks of appropriate antifungal treatment, and when at least 2 weeks have passed since the previous imaging study. 3. Clinical deterioration and microbiological isolation of a fungus resistant to all available antifungal treatments (including cases in which a specific antifungal cannot be administered due to the risk of unacceptable toxicity). 4. Rapidly progressive clinical deterioration despite the implementation of all available antifungal measures, conferring a poor prognosis for the patient. 3. Signing the informed consent form to participate in the clinical trial and to receive CD5CAR-CBNK therapy. If the patient is not in a condition to sign the informed consent form, consent will be requested from the family and patient consent for the study continuation will be obtained as soon as deemed possible. Exclusion Criteria: 1. An expected survival of less than four weeks due to a cause unrelated to the current fungal infection. 2. Patients with positive HIV serology. 3. Pregnant or breastfeeding women. 4. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clinic Barcelona
Barcelona, Barcelona, 08036, Spain
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