Page 52 - SaxoCell Annual Report 2021

ECP-CAR

One of the most relevant steps in the successful CAR-T cell therapy is the preparation of the
patient for the application of the CAR-T cells. The patient's "normal" immune cells would hinder
the growth and function of CAR-T cells, thus it is necessary to temporarily reduce or eliminate
the patient's immune cells by using chemotherapy. Moreover, in some cases, severe side effects
caused by a global cytokine release may occur due to the immune reaction upon CAR-T cell
therapy. To address this issue, a clinical trial will be conducted to determine if the
SaxoCell Projects impact the safety and efficacy of conventional CAR-T treatment. In ECP, the patient's blood cells
immunomodulation with extracorporeal photophoresis (ECP) prior to lymphodepletion can

are treated ex vivo with 8-methoxy psoralen, then irradiated with ultraviolet light (UV-A) and
reapplied to the patient, which is expected to eliminate immune cells and optimize the growth
and function of CAR-T cells.

The patients treated in this study will undergo complex analyses of their immune system before
and after ECP, helping us to understand (1) the complex immunological mechanisms on tumor
microenvironment induced by ECP but also (2) the individual characteristics and functionality of
the applied CAR-T cells. Taken together, the SaxoCell® project ECP-CAR will investigate the
additive effect of immune modulation by ECP in a randomized phase II study with regard to its
safety and efficacy.

Project Manager: Dr. Vladan Vucinic

Project Partners: University Hospital Leipzig, University of Leipzig, University Hospital Dresden

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