CD5CAR-NK Cells for Refractory Invasive Mold Disease
ConditionFungal Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFundacion Clinic per a la Recerca Biomédica
About this trial
CD5CAR-NK is a first-in-human, pilot, dose-escalation, and single-site study to evaluate the safety of CD5CAR-CBNK in patients with invasive mold diseases (IMD).
The study population consists of patients aged ≥18 years with refractory mold infections.
The number of patients treated will be 10. This is a dose-escalation study including 3 cohorts.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Persistence of positive cultures despite having received ≥2 weeks of appropriate antifungal treatment.
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.
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).
Disqualifiers
An expected survival of less than four weeks due to a cause unrelated to the current fungal infection.
Patients with positive HIV serology.
Pregnant or breastfeeding women.
Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
Trial design
Treatments tested in this trial
- CD5CAR-CBNK
Treatment groups
10 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov