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Starting soon Phase 1

CD5CAR-NK Cells for Refractory Invasive Mold Disease

NCT07454122 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2026-05
Last updated
2026-03-06

Condition(s) studied

Fungal Infection

Investigational drug(s) / intervention(s)

CD5CAR-CBNK

CD5CAR-CBNK: Allogeneic natural killer (NK) cells derived from umbilical cord blood (CB) units, genetically modified to express a chimeric antigen receptor (CAR) based on the CD5 receptor (CD5CAR).

Study summary

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evaluate the safety of allogeneic CD5CAR-CBNK cells in patients with refractory mold infection. — 28 days following the first infusion
    Number and proportion of patients with grade 3-4 treatment-related adverse events according to the Common Toxicity Criteria (CTCAE) version 5.0

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic Barcelona Barcelona Barcelona
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07454122 on ClinicalTrials.gov ↗ ← All trials in Spain