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)

Phase 1

Not yet recruiting

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

• Registration Number: NCT06699758
• Lead Sponsor: Cristina Calvo Rey

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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).

Secondary Outcome Measures

Name	Time	Method
Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells	6 months	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.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain