In recent years, cell therapies have developed alongside chemotherapy and immunotherapy to become a new pillar in the treatment of patients with blood and lymph gland cancer. In solid tumors, such as skin, lung, or bone and soft tissue cancer (sarcomas), they have not yet proven themselves as a treatment method. Tumor shrinkage was achieved only in rare cases, but the side effects were all the more severe. An international research group led by scientists from the National Center for Tumor Diseases (NCT/UCC) in Dresden has now succeeded for the first time in a phase 1 clinical trial in testing a novel cell therapy approach that also shows promise for solid tumors. The results were now published in the renowned journal Nature Medicine.

© Martin Wermke

In a phase 1 trial involving 40 patients, the research group investigated the use of T cell receptor (TCR)-engineered T cells. Using genetic engineering techniques, the researchers incorporated a kind of target identification into the T cells to enable them to recognize tumor-specific proteins. The newly tested IMA203 therapy targets the PRAME peptide, which is produced almost exclusively by tumors and not by healthy tissue. This enables the T cells to attack tumor cells in a targeted manner without damaging normal cells. PRAME is produced by many tumors, such as melanoma, ovarian cancer, sarcomas, and lung cancer.

© Martin Wermke

A good half of the people treated who had not responded to standard therapies previously responded to the therapy. The majority of them even responded over a period of eight months or several years. Compared to chemotherapy, which usually lasts three to six months, this is a significant advancement in treatment. The cell therapy was also well tolerated. Side effects such as fever or skin rash were mostly mild to moderate and only temporary.

“Based on these results, we can speak of a breakthrough,” says Prof. Martin Wermke, head and first author of the trail: “For the first time, we have achieved a lasting response in truly common solid tumors. The efficacy of IMA203 goes far beyond what we can achieve with our current chemotherapy and immunotherapy treatments. Not only do we have significantly more patients responding to treatment, but the effect is also lasting much longer. We now have patients who have not had a relapse of their tumor disease more than two years after receiving IMA203. Some of these patients may even have been permanently cured of their cancer.”

Cell therapy is a clear focus of Dresden University Medicine

“Cell therapies are virtually part of the DNA of the Dresden University Hospital,” adds Prof. Martin Bornhäuser, Director of Medical Clinic I and the NCT/UCC Dresden. He began setting up the cell therapy program at Dresden university medicine more than two decades ago: “The infrastructure we have developed over many years, primarily for patients with blood and lymph gland cancer, will help us in the future to offer innovative cell therapies such as IMA203 to as many patients as possible who are suffering from solid tumors.”

In a next step, IMA203 could be used in a larger trial in patients with melanoma who have not responded to conventional immune and targeted therapies. The NCT/UCC Dresden is testing other cell therapies for other types of skin cancer and lung cancer. “I would like to congratulate the scientists on their years of perseverance and the success they have now achieved,” said Prof. Esther Troost, Dean of TU Dresden's Faculty of Medicine. “The Faculty of Medicine's focus on oncology is bearing fruit and now gives cancer patients justified hope.”

Prof. Uwe Platzbecker, Medical Director of the University Hospital, said: “The first approvals for cell therapies to treat solid tumors are already in the pipeline, and we are working hard to prepare for these. Our goal is to be able to offer these innovative therapies to as many patients as possible.”

Publication:
Nature Medicine „Autologous T cell therapy for PRAME+ advanced solid tumors in HLA-A*02+ patients: a phase 1 trial“: https://doi.org/10.1038/s41591-025-03650-6

Contact:
Prof. Martin Wermke
NCT/UCC Early Clinical Trial Unit
National Center for Tumor Diseases (NCT/UCC) Dresden
Medical Clinic I, University Hospital Dresden

+49 351 458 7566

Anne-Stephanie Vetter
Staff Unit Public Relations of the Carl Gustav Carus Faculty of Medicine
at TUD Dresden University of Technology
National Center for Tumor Diseases (NCT/UCC) Dresden
+49 351 458 17903

www.tu-dresden.de/med

^{National Center for Tumor Diseases (NCT/UCC) Dresden
The National Center for Tumor Diseases (NCT/UCC) Dresden is a joint institution involving the German Cancer Research Center (DKFZ), the Carl Gustav Carus University Hospital Dresden, the Faculty of Medicine at TU Dresden, and the Helmholtz-Zentrum Dresden-Rossendorf (HZDR). The NCT Dresden is part of NCT, which has further sites in Berlin, Heidelberg, SouthWest (Tübingen-Stuttgart/Ulm), WERA (Würzburg, Erlangen, Regensburg, Augsburg) and West (Essen/Cologne).
The NCT is a long-term collaboration between the German Cancer Research Center (DKFZ), excellent partners in university medicine, and other outstanding research partners at various locations in Germany. The NCT is committed to rapidly and effectively integrating innovations in cancer research into clinical trials in order to successfully diagnose and treat cancer according to the latest research. Patients are research partners on an equal footing.
The Dresden center draws on the structures of the University Cancer Center Dresden (UCC), which was founded in 2003 as one of the first Comprehensive Cancer Centers (CCC) in Germany. Since 2007, the Dresden center has repeatedly been awarded the title of “Oncological Center of Excellence” by the German Cancer Aid (DKH).}