As part of a clinical study, the Early Clinical Trial Unit (ECTU) at NCT/UCC Dresden tested the cancer immunotherapy IMA401 for the first time in patients with advanced solid tumors. IMA401 is a so-called bispecific T-cell engager (TCER) that specifically links cancer cells with T cells, thereby directly activating the immune system to fight the tumor. To achieve this, the molecule simultaneously binds to two targets: a protein produced in tumor cells known as the tumor antigen MAGEA4/8, and a molecule on the surface of the body's immune cells (CD3). These immune cells, known as T lymphocytes, are thereby directed specifically to the tumor locations and activated so that they can destroy the cancer cells.
In the study now being presented, 61 patients with advanced tumors that no longer responded to standard treatments received IMA401 as an infusion, in some cases in combination with the already approved immunotherapy drug Pembrolizumab. "Our primary objectives were to demonstrate the safety of IMA401 and to determine the optimal dose for further development," explains study lead Prof. Martin Wermke, director of the NCT/UCC Early Clinical Trial Unit (ECTU) and professor of experimental tumor therapy.
Overall, the treatment was well tolerated: The most common treatment-related side effects were due to the intended activation of the immune system. Cytokine release syndrome occurred in 38 percent of patients and was mainly characterized by fever (grade 1 to 2 severity). In addition, temporary changes in blood counts were observed. These included lymphopenia in 33 percent of cases and reversible neutropenia in 31 percent.
The study demonstrated a response to treatment in several tumor types, including lung cancer, melanoma, and neuroendocrine tumors. However, the largest group of patients consisted of people with head and neck cancers. In this group, significant tumor shrinkage was observed in four out of 14 patients treated within the optimal dose range. In three of these four individuals, the response was still ongoing at the time of analysis. The median duration of response — meaning the period during which the treatment remained effective — was 8.8 months.
"The results of the study represent a significant advancement for our patients, for whom otherwise only very limited chemotherapy options are available in this situation," explained Martin Wermke, summarizing the findings. It is particularly exciting that IMA401 makes it possible to use tumor markers for immunotherapy that are not located on the surface of the tumor cell but are instead found within it. Due to its good tolerability, there is the possibility of combining IMA401 with other immunotherapies. We will soon be testing IMA401 in combination with a similar TCER targeting a different tumor marker in lung cancer. We hope this will lead to even greater effectiveness."
The Early Clinical Trial Unit (ECTU)
The Early Clinical Trial Unit (ECTU) at NCT/UCC Dresden specializes in conducting early-phase clinical trials. "We see our ECTU as a way of providing patients in the region with early access to new cancer therapies as safely as possible. The recently published study on IMA401 is a particularly prominent example of the effectiveness of this approach," enthused Prof. Martin Bornhäuser, one of the managing directors of the NCT/UCC Dresden and director of Medical Clinic I at the Carl Gustav Carus University Hospital Dresden.
"We will continue to support the outstanding work of the ECTU and consistently expand this area to further consolidate our leading position in the development of novel cancer therapies," emphasizes Prof. Uwe Platzbecker, Medical Director of the University Hospital Dresden (UKD).
"The presentation of the study results at the ASCO Annual Meeting and the simultaneous publication in Nature Medicine once again underscore the great international significance of Dresden's cancer research," added Prof. Esther Troost, Dean of the Faculty of Medicine at TUD.
The Study
The full study results will be presented on May 31, 2026, at the annual meeting of the American Society of Clinical Oncology (ASCO) and published simultaneously in Nature Medicine.
"A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability, and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination with a Checkpoint Inhibitor in Patients with Recurrent and/or Refractory Solid Tumors."
https://clinicaltrials.gov/study/NCT05359445
ClinicalTrials.gov Identifier: NCT05359445
