Immune response evaluation
Analyses of immune cell profile and kinetics were performed before and during treatment with zolbetuximab in combination with ZA with/without IL-2. Changes in immunological profile over time and induction of ADCC by zolbetuximab across treatment arms were analyzed. The immunomodulatory effects of ZA/IL-2 in combination with zolbetuximab during treatment were assessed by examining short-term, mid-term, and long-term changes (Fig.  Definition of time frames for the evaluation of immunomodulatory effect of ZA/IL-2 in combination with zolbetuximab. Immune phenotyping of PBMCs was performed by the central lab, TRON gGmbH, according to TRON working instructions. The number of T cell, γδ T cells, NK cells, B cells, monocytes and TWhether the observed immunological profiles had an effect on defined modes of action of zolbetuximab was evaluated by harvesting and testing ex vivo PBMCs as a source for ADCC at Day 1 before the first ZA or ZA + IL-2 treatment; Day 43 before the second ZA or ZA + IL-2 treatment; and posttreatment on Days 8, 22, 50, 64, and 85. The ADCC assay and measurements were developed and performed by Ganymed and are described in detail elsewhere (Tureci et al. 