Clinical Trials
Immunotherapy Clinical Study
KFRM supports the preparation of a first-in-human Phase I clinical trial evaluating a novel immunotherapy approach leveraging vaccine-induced T cells.
Targeted Individualised Immunotherapy Leveraging Vaccine-Induced T Cells
Cancer cells express unique molecular structures including antigens that distinguish them from healthy tissue. These tumour-associated antigens can be recognised by specialised T lymphocytes, enabling the immune system to identify malignant cells.
Over more than 25 years of research at the tumour immunology laboratory at Krankenhaus Nordwest, personalised vaccination strategies have been developed and investigated to induce antigen-specific T-cell responses.
While these approaches have contributed to scientific understanding and may support disease stabilisation in certain contexts, tumour regression is limited by the number and phenotypes of tumour-reactive T cells generated in vivo.
The objective of this clinical study is to investigate whether this limitation can be overcome by isolating vaccine-activated T lymphocytes, expanding them ex vivo, and reinfusing them under controlled clinical conditions.
Importantly:
- the approach uses the patient's own immune cells
- the cells are not genetically modified
- the approach builds directly on two decades of translational immunology research
This investigator-initiated Phase I study represents the translation of laboratory research into a clinical research setting.
Process Overview
Trial Status
- Clinical Trial Application planned to be submitted to Paul-Ehrlich Institute (the German regulatory agency) in Q2 2026
- Cell expansion partner: Cellex (Cologne)
- Phase I start anticipated within 6–9 months of final approvals
What This Means in a Clinical Context
Patients who have previously shown relevant immune responses from vaccines in research or clinical settings may be eligible for participation, subject to study enrollment criteria.
This study represents the clinical translation of decades of foundational research may contribute to future treatment strategies for immunotherapies.
Interested in Learning More?
If you are a patient, carer, or referring physician and would like to learn more about this trial, please get in touch.
This form is for general enquiries only. It is not intended for submission of medical or health-related information.