Personalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial.

ABSTRACT: New treatment approaches are warranted for patients with advanced melanoma refractory to immune checkpoint blockade (ICB) or BRAF-targeted therapy. We designed BNT221, a personalized, neoantigen-specific autologous T cell product derived from peripheral blood, and tested this in a 3 + 3 dose-finding study with two dose levels (DLs) in patients with locally advanced or metastatic melanoma, disease progression after ICB, measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1) and, where appropriate, BRAF-targeted therapy. Primary and secondary objectives were evaluation of safety, highest tolerated dose and anti-tumor activity. We report here the non-pre-specified, final results of the completed monotherapy arm consisting of nine patients: three at DL1 (1 × 10⁸

SUBMITTER: Borgers JSW 

PROVIDER: S-EPMC11922764 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature