biostudies-literatureWermke MNCATS NIH HHSCancer Prevention and Research Institute of Texas (Cancer Prevention Research Institute of Texas)NCRR NIH HHSNCI NIH HHSCancer Prevention and Research Institute of Texas2365-2374https://www.ebi.ac.uk/biostudies/studies/S-EPMC12283372biostudies-literatureUnknown31(7)In contrast to chimeric antigen receptor T cells, T cell receptor (TCR)-engineered T cells can target intracellular tumor-associated antigens crucial for treating solid tumors. However, most trials published so far show limited clinical activity. Here we report interim data from a first-in-human, multicenter, open-label, 3 + 3 dose-escalation/de-escalation phase 1 trial studying IMA203, an autologous preferentially expressed antigen in melanoma (PRAME)-directed TCR T cell therapy in HLA-A*02⁺ patients with PRAME⁺ recurrent and/or refractory solid tumors, including melanoma and sarcoma. Primary objectives include the evaluation of safety and tolerability and the determination of the maximum tolerated dose (MTD) and/or recommended dose for extension. Secondary objectiveNature medicineAutologous T cell therapy for PRAME<sup>+</sup> advanced solid tumors in HLA-A*02<sup>+</sup> patients: a phase 1 trial.PMC12283372L30 CA123720M01 RR000847DP150029UM1 TR004906R01 CA306089Singh-Jasuja HHolderried TAWKrishna DMendrzyk RReinhardt CChatterjee MAraujo DMHossain MBFritsche JBrossart PTsimberidou AMSatelli AWeinschenk TSchoor OHengler SHilf NMayer-Mokler AWagner CBritten CMAslan KWermke MJazaeri AAReshef RBunk SMohamed APozo KKursunel MALuke JJGulde SBokemeyer CKalra MRammensee HGWalter SWetzko KBackert LMaurer DSchuster HHukelmann JLetizia MAlsdorf WfalseAutologous T cell therapy for PRAME<sup>+</sup> advanced solid tumors in HLA-A*02<sup>+</sup> patients: a phase 1 trial.In contrast to chimeric antigen receptor T cells, T cell receptor (TCR)-engineered T cells can target intracellular tumor-associated antigens crucial for treating solid tumors. However, most trials published so far show limited clinical activity. Here we report interim data from a first-in-human, multicenter, open-label, 3 + 3 dose-escalation/de-escalation phase 1 trial studying IMA203, an autologous preferentially expressed antigen in melanoma (PRAME)-directed TCR T cell therapy in HLA-A*02⁺ patients with PRAME⁺ recurrent and/or refractory solid tumors, including melanoma and sarcoma. Primary objectives include the evaluation of safety and tolerability and the determination of the maximum tolerated dose (MTD) and/or recommended dose for extension. Secondary objective2025-01-01T00:00:00Z2025 Jul2026-07-15T12:29:53.288Z2025-08-13T03:04:48.385ZS-EPMC122833724020519810.1038/s41591-025-03650-6