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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. These cells will be administered intranasally.
Hospital Universitario La Paz
Madrid, Madrid, Spain
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).
Time frame: 6 months
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.
Time frame: 6 months
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