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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm Group 1 | Experimental | Administration of a total of 3x106 cells administered over three 1x106cell doses. |
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| Intervention arm Group 2 | Experimental | Administration of a total of 15x106 cells administered over three 5x106cell doses. |
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| Intervention arm Group 3 | Experimental | Administration of a total of cumulative 30x106 cells administered over three 10x106cell doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. | Other | CD45RA- memory T lymphocytes cells sourced from healthy peripheral blood mononuclear cells male donors. These cells will be administered intranasally. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
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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).
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