![]() Partial responses were seen in 18% of patients with dose-dependent “on-target, off-tumor” toxicity and a maximum tolerated dose of 1.0x10⁸ cells.ĬD8+ T cell reactivity towards tumor mutation-derived neoantigens is widely believed to facilitate the antitumor immunity induced by immune checkpoint blockade (ICB). Production of TCR-modified cells as described leads to highly potent T cells. Partial responses were seen in 2/11 (18%) evaluable patients and persistence of 1D3HMCys T cells corresponded to infused cell dose. The study was prematurely terminated because of dose-dependent toxicity, concerning skin (10/12), eyes (3/12), ears (4/12) and CRS (5/12), with seven patients experiencing grade 3-5 toxicity. Patient 1 received 4.6x10⁹ 1D3HMCys T cells and experienced grade 5 toxicity after nine days. Twelve pretreated metastatic cutaneous (n=7) and uveal (n=5) melanoma patients were included. Feasibility, safety, and objective response rate were assessed. ![]() Patients received a single infusion of transgenic T cells in a dose-escalating manner. In this phase Ib/IIa trial, peripheral blood T cells from HLA-A2*02:01-positive patients with unresectable stage IIIC/IV melanoma expressing MART-1 were selected and stimulated with anti-CD3/CD28 beads, transduced with a modified MART-1(26–35)-specific 1D3 TCR (1D3HMCys) and expanded in IL-7 and IL-15. We investigated safety and feasibility of adoptive transfer of autologous T cells expressing MART-1-specific TCR, cultured to have less differentiated phenotypes, in patients with metastatic melanoma. Adoptive cell therapy with peripheral blood T cells expressing transgenic T cell receptors (TCR) is an innovative therapeutic approach for solid malignancies.
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