A Phase 1 interventional study of CD5CAR-CBNK in Fungal Infection, sponsored by Fundacion Clinic per a la Recerca Biomédica. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Fundacion Clinic per a la Recerca Biomédica · Phase 1, Interventional, and Treatment
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.
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).
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 10 is below the median of 68 across 164 interventional studies indexed under Mycoses.
Browse Mycoses studies →Fundacion Clinic per a la Recerca Biomédica is the lead sponsor of 64 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Genetic: CD5CAR-CBNK
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).
Genetic: CD5CAR-CBNK
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).
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).
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 infusion
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 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: 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 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.
Time frame: 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
Time frame: 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.
Time frame: During the first year after first administration
Assess the efficacy of CD5CAR-CBNK cells.
Response rate
Time frame: at day 15, day 28, 6 and 12 weeks.
Assess the efficacy of CD5CAR-CBNK cells.
Overall Survival (OS)
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.
Survival rate
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.
Overall response rate (ORR)
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 to response calculated from the day of infusion to the date when the patient first meets the criteria for partial or complete response.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: During the first year after first administration
To quantify persistence and kinetics of allogeneic CD5CAR-CBNK cells in blood after administration.
CD5 expression
Time frame: 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
Time frame: During the first year after first administration
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion Clinic per a la Recerca Biomédica