Feasibility and safety profile of intranasal third-party allogeneic CD45RO+/RA- memory T cells: a phase I clinical trial (vRELEASE-I NCT06699758)
Abstract
Background: Respiratory viral infections remain a major global health challenge, particularly in immunocompromised populations. Although adoptive cell therapies using virus-experienced memory T lymphocytes have demonstrated safety and effectiveness when administered intravenously, the safety profile and feasibility of intranasal delivery of immune effector cells in humans was not previously assessed.
Methods: vRELEASE I (NCT06699758) represents a phase I, single-center, open-label, dose-escalation study designed to evaluate the safety profile and feasibility of intranasal administration of off-the-shelf, allogeneic CD45RO+/RA- memory T lymphocytes derived from a third-party male donor in healthy female adult volunteers. The study employed a conventional 3+3 dose-escalation design, evaluating three dose levels (1 × 106, 5 × 106, and 10 × 106 cells per dose). Each participant received three intranasal administrations at 2-h intervals. Safety assessments included monitoring for adverse events and dose-limiting toxicities (DTLs). The local persistence of donor-derived cells in the nasal mucosa was evaluated using fluorescence in situ hybridization (FISH).
Results: Intranasal administration was completed as planned in all nine treated participants. No treatment-emergent adverse events were observed in any cohort during the seven-day safety follow-up period. The highest planned dose, 10 × 106 cells per administration, was delivered to three participants without DLTs during…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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