Page 45 - SaxoCell Annual Report22/23

Mod. ECP-CAR
ATMP

In the ECP-CAR project, the analysis of cellular subpopulations including their molecular profiles
and effector functions in a cell therapeutic real-world system of a clinical study on the effects of
an implemented extracorporeal photopheresis (ECP) is performed. The procedure of ECP, which is
well known from other indications, such as the treatment of graft-vs-host disease after allogeneic
stem cell transplantation, in terms of efficacy, safety and mechanism of action, currently does not
present itself as a regular component of the sequence of therapeutic application of CAR-T cells. As
an innovative intervention, ECP as a preparative, immunomodulatory component of CAR-T cell
treatment is now being preempted here. In addition to positive effects on clinical endpoints, such
as a reduction in inflammatory side effects, positive effects on in vivo expansion, persistence and
functionality of CAR-T cells are also hypothesized.

Project lead: Vladan Vucinic

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

The core of the work was originally a study-by-study analysis of the effects of ECP treatment in
combination with CAR-T cell therapy on cellular subpopulations including their molecular profiles
and effector functions. As an innovative intervention, ECP should precede CAR-T cell infusion as a
preparatory immunomodulatory component. This novel clinical procedure was to be used as part
of a nonapplicant-funded prospective intervention study (PhotoCAR, phaseI/II) in CAR T-cell
therapy.

Unfortunately, the Photo-CAR study could not start as planned because the ECP procedure was
classified by the PEI as an ATMP and in combination with CAR-T cells as an investigational product.
We worked closely with the PEI for clarification and discussion, and the submission of literature
data and our own results from the aforementioned assays should increase the chances of
conducting and starting the PhotoCAR study. Unfortunately, the PEI requirements exceed the
available capacity to conduct an academic study.

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