To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte SolutionPhase 1vRELEASE INCT06699758
A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)
A Phase 1 study testing CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. in people with To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution, run by Cristina Calvo Rey at 1 site in Spain.
Trial summary
Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution
- What is being tested?
- CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2025to 30 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects between 18 - 55 years of age.
- Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Patients with the ability to comprehend and sign the informed consent.
- Written informed consent obtained prior to any screening procedures.
- Subjects in good health with no baseline disease of any kind.
Who cannot join
- Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
- Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
- Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
- Have a known history of drug substance abuse.
- Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
Show all 9Show fewer
- Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.
- Any condition or situation precluding or interfering with the compliance with the protocol.
- Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age.
- Being tested
- CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.Other
CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. These cells will be administered intranasally.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm Group 1 | Experimental | Administration of a total of 3x106 cells administered over three 1x106cell doses. Receives: Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. |
| Intervention arm Group 2 | Experimental | Administration of a total of 15x106 cells administered over three 5x106cell doses. Receives: Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. |
| Intervention arm Group 3 | Experimental | Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses. Receives: Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability will be evaluated based on the frequency and attribute of DLT (dose limiting toxicities) in the first 7 days after solution administration and the incidence of all AEs and serious adverse events (SAEs) during study period.
The primary endpoint will be DLT, defined as any grade 3 or higher adverse event (as defined in the Common Terminology Criteria for Adverse Events (CTCAE) version 5) with an attribution of definitely or probably related to the product administration.
The highest dose found safe in the present study will be determined as the maximum tolerated dose (MTD).
Measured: 6 months
Secondary outcomes (1)
Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells
Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells, confirmed by the detection of male donor cells through nasopharyngeal aspirate and the presence of a Y chromosome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start5 Feb 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte SolutionStudies 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
- Sequential
- Model description
- Standard 3+3 dose escalation design to determine the optimal dosage of the investigational product, consisting of CD45RA- memory T lymphocytes, for intranasal administration in healthy female volunteers. The dose escalation will be based on the observed occurrence of dose-limiting toxicities (DLTs).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina Calvo Rey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina Calvo Rey, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699758
- Sponsor's protocol ID
- HULP: 6796
- Acronym
- vRELEASE I
- Status last verified
- Feb 2025
- First submitted
- 19 Nov 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label, Dose-Escalation Clinical Trial to Assess the Safety and Tolerability of an Intranasal Memory T Lymphocytes Solution in Adult Females: vRELEASE I. (vRELEASE I)
- ClinicalTrials.gov ID
- NCT06699758
- Acronym / sponsor ID
- vRELEASE I / HULP: 6796
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cristina Calvo ReyUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 21 Nov 2024 (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.
Proof-of-concept trial to assess the safety and tolerability of intranasal administration of a male donor memory T lymphocyte solution in females aged between 18 - 55 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Standard 3+3 dose escalation design to determine the optimal dosage of the investigational product, consisting of CD45RA- memory T lymphocytes, for intranasal administration in healthy female volunteers. The dose escalation will be based on the observed occurrence of dose-limiting toxicities (DLTs).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm Group 1 | Experimental | Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.Administration of a total of 3x106 cells administered over three 1x106cell doses. |
| Intervention arm Group 2 | Experimental | Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.Administration of a total of 15x106 cells administered over three 5x106cell doses. |
| Intervention arm Group 3 | Experimental | Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects between 18 - 55 years of age.
- Participants are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Patients with the ability to comprehend and sign the informed consent.
- Written informed consent obtained prior to any screening procedures.
- Subjects in good health with no baseline disease of any kind.
Key exclusion criteria (9 listed)
- Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- Participants who are currently under medical follow-up for any medical condition or who are regularly taking medication for any condition.
- Subject has experienced symptoms consistent with a respiratory infection within the 7 days prior to the administration of the investigational treatment.
- Have a known history of human immunodeficiency virus infection, Hepatitis B or Hepatitis C; testing is not required in the absence of prior documentation or known history.
- Have a known history of drug substance abuse.
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 |
|---|---|---|
| CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. These cells will be administered intranasally. | Other | Intervention arm Group 1, Intervention arm Group 2, Intervention arm Group 3 |
Primary outcome
Safety and tolerability
Time frame: 6 months
Safety and tolerability will be evaluated based on the frequency and attribute of DLT (dose limiting toxicities) in the first 7 days after solution administration and the incidence of all AEs and serious adverse events (SAEs) during study period. The primary endpoint will be DLT, defined as any grade 3 or higher adverse event (as defined in the Common Terminology Criteria for Adverse Events (CTCAE) version 5) with an attribution of definitely or probably related to the product administration. The highest dose found safe in the present study will be determined as the maximum tolerated dose (MTD).
1 secondary outcome
Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. in people with To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution, run by Cristina Calvo Rey 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 10 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 6 months). 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 10 Sep 2025; AzTrials last refreshed its copy on 3 Nov 2026.