Clinical trial NCT06699758: 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)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: To Assess the Safety and Tolerability of Intranasal Administration of a Male Donor Memory T Lymphocyte Solution
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Persistence of donor cells in the nasal mucosa of participants post-administration of treatment cells
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: