Fungal InfectionPhase 1CD5CAR-NKNCT07454122
CD5CAR-NK Cells for Refractory Invasive Mold Disease
A Phase 1 study testing CD5CAR-CBNK in people with Fungal Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fungal Infection
- What is being tested?
- CD5CAR-CBNK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- May 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036
Carolinia Garcia Vidal, Dr., +34932275400, cgarciav@clinic.cat
About this study
Official title: Off-the-shelf CD5CAR-NK Cells for Refractory Invasive Mold Disease: Phase I Clinical 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.
Read the 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).
- Conditions
- Fungal Infection
- Being tested
- CD5CAR-CBNK
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5CAR-CBNKGenetic
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. 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. Receives: Genetic: CD5CAR-CBNK |
| Cohort 2 | Experimental | 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). Receives: Genetic: CD5CAR-CBNK |
| Cohort 3 | Experimental | 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). Receives: Genetic: CD5CAR-CBNK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days following the first infusion
Secondary outcomes (16)
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Incidence of all grade >3 adverse events (AEs) as per CTCAE version 5.0.
Measured: at 6 and 12 weeks
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:
- Cytokine release syndrome (CRS) ii. Immune effector cell-associated neurotoxicity syndrome (ICANS) iii. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis (IEC-HS) iv. Prolonged cytopenia.
Measured: at 6 and 12 weeks
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.
Measured: During the first year after first administration
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
Measured: During the first year after first administration
Evaluate the safety and tolerability of CD5CAR-CBNK cells.
Number and percentage of patients with Serious Adverse Events (SAEs) according to CTCAE version 5.0.
Measured: During the first year after first administration
Assess the efficacy of CD5CAR-CBNK cells.
Response rate
Measured: at day 15, day 28, 6 and 12 weeks.
Assess the efficacy of CD5CAR-CBNK cells.
Overall Survival (OS)
Measured: 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.
Survival rate
Measured: 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.
Overall response rate (ORR)
Measured: 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 to response calculated from the day of infusion to the date when the patient first meets the criteria for partial or complete response.
Measured: During the first year after first administration
Assess the efficacy of CD5CAR-CBNK cells.
Duration of response: defined as the time between first response and loss of response.
Measured: During the first year after first administration
Assess the efficacy of CD5CAR-CBNK cells.
Event-free survival (EFS) calculated from CD5CAR-CBNK cell infusion and study inclusion to the date of first occurrence of any of the following events:
(i) Fungal disease progression (radiological or clinical). (ii) Loss of response or fungal recurrence (iii) Severe therapy-related toxicity. (iv) Death for any cause.
Measured: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Number of circulating CD5CAR-CBNK cells in peripheral blood
Measured: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Changes in serum pro-inflammatory and anti-inflammatory cytokines
Measured: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
CD5 expression
Measured: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Percentage of transduction, T-cell, NK-cell and B-cell subsets, and exhaustion and senescence population
Measured: During the first year after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454122
- Sponsor's protocol ID
- 2025-524638-24-00
- Other IDs
- 2025
- Acronym
- CD5CAR-NK
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-the-shelf CD5CAR-NK Cells for Refractory Invasive Mold Disease: Phase I Clinical Trial.
- ClinicalTrials.gov ID
- NCT07454122
- Acronym / sponsor ID
- CD5CAR-NK / 2025-524638-24-00
- Conditions
- Fungal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Genetic: CD5CAR-CBNKThe 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. 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 | Experimental | Genetic: CD5CAR-CBNKThe 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 | Experimental | Genetic: CD5CAR-CBNKThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD5CAR-CBNKAllogeneic 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). | Genetic | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Evaluate the safety of allogeneic CD5CAR-CBNK cells in patients with refractory mold infection.
Time frame: 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
16 secondary outcomes
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
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Time frame: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Time frame: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Time frame: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
Time frame: During the first year after first administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD5CAR-CBNK in people with Fungal Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Garcia Vidal, Dr. (+34932775400, cgarciav@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of allogeneic CD5CAR-CBNK cells in patients with refractory mold infection. (time frame: 28 days following the first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.