Autologous TAC targeting HER2 shows promise in treatment of metastatic solid tumours
20 giờ trước
A phase I study has shown the safety and feasibility of treatment with TAC01-HER2, an autologous T-cell product targeting the human epidermal growth factor receptor 2 (HER2), in patients with advanced or metastatic solid tumours.
Twenty-three patients with HER2-positive solid tumours participated in this study.
The most common treatment-related adverse event (AE) was cytokine release syndrome (60.9 percent), followed by anaemia (21.7 percent) and increased alanine aminotransferase (21.7 percent). The recommended phase II dose was 6-8 × 106 cells/kg.
No treatment-related deaths or AEs leading to study discontinuation occurred.
Two patients with gastric and gastroesophageal junction (GEJ) cancers showed partial responses (PRs). Disease control rate (stable disease or PR) was 61.1 percent in 18 patients with evaluable tumours.
The median progression-free survival was 2.6 months, and the overall survival rate at 6 months was 57.9 percent (95 percent confidence interval, 36.3‒76.9).
Notably, the investigators observed the persistence of T-cell antigen coupler (TAC) T cells in peripheral blood in all patients at least day 29 after the initial infusion.
“TAC01-HER2 showed manageable toxicity and early efficacy for patients with HER2-positive gastric, GEJ, or esophageal adenocarcinoma who have undergone extensive previous treatments,” the investigators said. “These results suggest that TAC may offer a promising approach to control T-cell activity through cellular therapy.”
TAC is a genetically engineered receptor that recruits the native T-cell receptor upon recognizing an antigen, according to the investigators.
“The downstream activation of TAC T cells has been effective against tumours in preclinical models and is safer than chimeric antigen receptor T cells,” they said.