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)

NCT06699758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution

Interventions

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.

Sponsors & Collaborators

  • Cristina Calvo Rey

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699758 on ClinicalTrials.gov