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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD5CAR-CBNK
GeneticAllogeneic 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).
Treatment groups
10 Participants
are divided into 3 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety of allogeneic CD5CAR-CBNK cells in patients with refractory mold infection.
Number and proportion of patients with grade 3-4 treatment-related adverse events according to the Common Toxicity Criteria (CTCAE) version 5.0
Time frame
28 days following the first infusionSecondary outcomes
1
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Incidence of all grade \>3 adverse events (AEs) as per CTCAE version 5.0.
Time frame
at 6 and 12 weeks2
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Number and percentage of patients with Adverse Events of Special Interest (AESI) throughout the study duration. The following AEs will be considered as AESI: i. Cytokine release syndrome (CRS) ii. Immune effector cell-associated neurotoxicity syndrome (ICANS) iii. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis (IEC-HS) iv. Prolonged cytopenia.
Time frame
at 6 and 12 weeks3
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Procedure-related mortality rate (PRM), defined as any death not related to the underlying disease or fungal infection.
Time frame
During the first year after first administration4
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Number and proportion of patients with grade 3-4 treatment-related adverse events according to the Common Toxicity Criteria (CTCAE) version 5.0
Time frame
During the first year after first administrationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: