€2.5 million in funding for CAR-T cell study led by Erlangen researchers at the National Center for Tumor Diseases

The National Center for Tumor Diseases (NCT) is funding the multicenter CURE-GvHD study, led by Uniklinikum Erlangen, with €2.5 million from the Federal Ministry of Research, Technology, and Space. A CAR-T cell approach is being evaluated for patients with severe chronic graft-versus-host disease (cGvHD).

Allogeneic blood stem cell transplantation, the transfer of donated stem cells, is the only curative option for many patients with leukemia or lymphoma. The effectiveness of this therapy is based on the graft-versus-leukemia effect (GvL): Using the donor’s immune cells, the patient’s immune system targets and destroys tumor cells. Unfortunately, this often leads to an unwanted effect in which the donor’s immune cells attack the recipient’s healthy tissue: Graft-versus-host disease, GvHD) is a complication that can occur acutely (aGvHD) or chronically (cGvHD) and has a high mortality rate. Researchers at Department of Medicine 5 – Hematology and Oncology at Uniklinikum Erlangen, together with partners from NCT aim to evaluate an innovative CD19-CAR-T cell therapy approach in the CURE-GvHD study. The goal is to develop a new and effective treatment option for patients with severe cGvHD. CURE-GvHD stands for “A multicenter phase I study of autologous CD19 CAR T cells for therapy refractory chronic GvHD.”

“cGvHD can affect a variety of organs and mimic known autoimmune diseases,” explains Prof. Dr. Silvia Spörl. The senior physician at Department of Medicine 5 and head of the Early Clinical Trial Unit at CCC Erlangen-EMN is the principal investigator for the study. “We know that cGvHD shares pathological features with autoimmune diseases, in whose pathogenesis B cells play a key role.” These immunological connections and the positive experiences Erlangen researchers have already had with CAR-T cells led to the study hypothesis, which is now being clinically tested in CURE-GvHD.

“For several years now, we have been researching CAR-T cells, which are the T cells of the body’s own immune system. Using genetic engineering, we modify them so they can recognize and destroy target cells such as B cells,” explains Prof. Dr. Andreas Mackensen, director of Department of Medicine 5, where the study is primarily conducted. “We produce the CAR-T cells in our own cleanrooms and use them to treat patients with leukemia, lymphoma, and autoimmune diseases.” As recently as September 2025, Erlangen experts published the results of the world’s first treatment of therapy-resistant, severe ulcerative colitis using CD19-CAR-T cells.

To produce CD19-CAR-T cells, immune cells (T lymphocytes) are collected from patients and genetically modified to recognize the surface molecule CD19. CD19 is characteristic of B lymphocytes but also of so-called plasmablasts, which are dysregulated in many autoimmune diseases. Preliminary studies have already shown that plasmablasts are also elevated in cGvHD. “Based on these immunological connections, we suspect that CD19-CAR-T cells may also be effective in cGvHD,” says Prof. Spörl. “As part of our multicenter phase I study, we aim to evaluate the feasibility of such a therapy and, above all, its safety and tolerability.”

Expertise from across Germany

The team at Uniklinikum Erlangen is primarily responsible for the study. Additionally, researchers from NCT WERA (University Hospitals of Regensburg, Würzburg, and Augsburg), NCT Berlin (Charité – Universitätsmedizin Berlin), and NCT West (University Hospital Cologne) are participating. Furthermore, a patient representative from NCT Dresden and another from NCT WERA are involved, supporting the study’s implementation from the patient perspective.

About the NCT

The National Center for Tumor Diseases (NCT) is a long-term collaboration between the German Cancer Research Center (DKFZ), leading partners in university medicine, and other outstanding research institutions at various locations in Germany. Uniklinikum Erlangen is part of NCT WERA, whose partners alongside the DKFZ include the university hospitals and universities of Würzburg, Erlangen, Regensburg, and Augsburg. The NCT’s goal is to efficiently and rapidly translate innovations in cancer research in Germany into clinical studies, enabling successful cancer diagnosis and treatment based on the latest scientific advances while maintaining a high quality of life. Patients are considered as collaborative partners on an equal footing with researchers.

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