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
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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