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) (vRELEASE I)

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 Overview

• Status: Completed
• Conditions: To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution
• Intervention / Treatment: Other: CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm Group 1; Administration of a total of 3x106 cells administered over three 1x106cell doses.	Other: 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.
Experimental: Intervention arm Group 2; Administration of a total of 15x106 cells administered over three 5x106cell doses.	Other: 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.
Experimental: Intervention arm Group 3; Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Cristina Calvo Rey

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HULP: 6796

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No