[⁶⁸Ga]Ga-interleukin-2 for imaging activated T-lymphocytes: biochemical characterization and phase I study in normal subjects.

ABSTRACT:

Purpose

This study aimed to develop a ready-to-use kit for ⁶⁸Ga-labelling of interleukin-2 (IL2) facilitating PET imaging of activated T-lymphocytes.

Methods

Human recombinant IL2 (hrIL2) and Aldesleukin (desIL2), conjugated with two different chelators (NODAGA and THP) were compared. Conjugated-IL2 was stored, freeze-dried at -80 °C and radiolabelled at room temperature. In vitro quality controls (iTLC, HPLC, SDS-PAGE, spectrometry and binding assays on activated T-lymphocytes) and in vivo biodistribution studies in BALB/c mice, were performed. The shelf life of the lyophilized kits was assessed up to 6 months of storage, by iTLC, HPLC and SDS-PAGE. First-in-human study was conducted in 5 volunteers by performing [⁶⁸Ga]Ga-THP-desIL2 PET/CT acquisitions

SUBMITTER: Signore A 

PROVIDER: S-EPMC12660392 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature