CD5CAR-NK Cells for Refractory Invasive Mold Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD5CAR-CBNK.
- Who it may be relevant to
- Registry conditions: Fungal Infection. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Off-the-shelf CD5CAR-NK Cells for Refractory Invasive Mold Disease: Phase I Clinical Trial.
Overview
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.
Detailed description
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. The dose escalation scheme will follow the following scheme:
Cohort 1(3 patients) The sentinel patient of cohort 1 will receive 10 x106 CAR+ cells of CD5CAR-CBNK at day 0. Intra-patient safety will be reviewed daily following the first dose. The second dose (day+3) and third (day+6) will only be administered after a safety review from clinicians that confirms the absence of dose-limiting toxicities (DLTs).
Cohort 1 is planned to include 3 evaluable patients. If a patient does not receive the full planned dosing schedule (all 3 doses), additional patients will be enrolled until at least 3 patients have completed the full prescribed treatment for this cohort. Escalation to Cohort 2 will only occur once safety data from 3 fully-treated patients have been reviewed.
The first subject in each cohort will be dosed and undergo a safety observation period between administrations. The second subject will be dosed 7 days after the first subject completes treatment and after review of safety data. The third subject will be dosed 3 days after the last dose of the second subject, subject to confirmation of acceptable safety.
Cohort 2 (3 patients) The sentinel patient of cohort 2 will receive 10 x106 CAR+ cells of CD5CAR-CBNK at days 0,3 and 6 followed by 25 x106 CAR+ cells at days 9 and 12. Intra-patient safety will be reviewed daily following the first 25 million dose. The dose at day +12 will only be administered after a safety review from clinicians that confirms the absence of dose-limiting toxicities (DLTs).
Cohort 3 (4 patients) The sentinel patient of cohort 3 will receive 10 x106 CAR+ cells of CD5CAR-CBNK at days 0,3 and 6 followed by 25 x106 CAR+ cells at days 9 and 12, and additionally 50 x106 CAR+ cells at days 15 and 18. In this occasion, intra-patient safety will be reviewed daily following the first 50 million dose. The dose at day +18 will only be administered after a safety review from clinicians that confirms the absence of dose-limiting toxicities (DLTs).
Interventions
- Genetic 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).
Primary outcome measures
- Evaluate the safety of allogeneic CD5CAR-CBNK cells in patients with refractory mold infection. [Time frame: 28 days following the first infusion]
Secondary outcome measures (12)
- Evaluate the safety and tolerability of CD5CAR-CBNK cells. [Time frame: at 6 and 12 weeks]
- Evaluate the safety and tolerability of CD5CAR-CBNK cells. [Time frame: at 6 and 12 weeks]
- Evaluate the safety and tolerability of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
- Evaluate the safety and tolerability of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
- Evaluate the safety and tolerability of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: at day 15, day 28, 6 and 12 weeks.]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: at day 28, 6 and 12 weeks from the first CD5CAR-CBNK cell infusion and from study inclusion.]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: at day 28, 6 and 12 weeks from the first CD5CAR-CBNK cell infusion and from study inclusion.]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: at day 28, 6 and 12 weeks from the CD5CAR-CBNK cell infusion and inclusion of the patient.]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
- Assess the efficacy of CD5CAR-CBNK cells. [Time frame: During the first year after first administration]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- 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:
- 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).
- Rapidly progressive clinical deterioration despite the implementation of all available antifungal measures, conferring a poor prognosis for the patient.
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clinic Barcelona — Barcelona
Identifiers
NCT: NCT07454122 · 2025-524638-24-00