multimmune GmbH

..........delivering innovative cancer theranostics

FOR PATIENTS

The safety and tolerability of ex vivo TKD/IL-2 stimulated, autologous NK cells has previously been demonstrated in patients with metastasized colorectal and non-small cell lung cancer (NSCLC) in a phase I clinical trial.

Based on promising clinical results of the previous study, a multi-centre randomised phase II clinical study is currently underway. The primary objective of this multicenter proof-of-concept trial is to examine whether an adjuvant treatment of patients with non small lung cell carcinoma (NSCLC) after platinum-based radiochemotherapy (RCTx) with TKD/IL-2 activated, autologous NK cells is clinically effective. As we have already shown that a membrane Hsp70-positive tumor phenotype is associated with poor clinical outcome, only patients that have membrane Hsp70-positive tumors can be recruited into the trial.

The primary endpoint of this study will be a comparison of progression-free survival of patients treated with ex vivo activated NK cells with that of patients who were treated with RCTx alone. Secondary endpoints in both study groups are overall survival, toxicity, quality-of-life, and biological responses.

This study is currently recruiting patients in Participating Study Sites in Germany. Further details on the trial and the inclusion and exclusion criteria can be found here.