Phase 1 Study: Induction of Systemic Immune Responses in Metastatic Breast Cancer Patients by Vaccination With a CD80-modified, Devitalized HLA-*A0201+ Breast Cancer Cell Line (KS24.22)
The trial was designed as an open label phase-I. Informed consent was given twice by the
patients (1st for HLA-typing, 2nd for participation in the vaccination trial).
The first four vaccinations, which were given every two weeks, were followed by four monthly
vaccinations. Additional vaccinations were permitted on request for patients who exhibited
stable disease (SD).
Immediately before administration, KS24.22 cells were thawed and lethally irradiated.
KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml
syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given
i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety of KS24.22 administration
University Hospital Tuebingen
Germany: Paul-Ehrlich-Institute, Langen, Germany
01 KV 9540