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Datasets  >  clinical study dataset  >  RCC phase 2 trial

RCC phase 2 trial

clinical study dataset

Data have been obtained from a phase 2 study testing PME-CD40L DC in RCC patients with clear cell histology.

The Phase 2 trial has the same general design, dosing regimen, endpoints, and immunomonitoring plan as the completed RCC trial.
However, the Phase 2 study tests the improved RCC product (i.e., PME-CD40L DC) and is restricted to RCC patients with clear cell histology.

As predicted from the in vitro data, the improved PME-CD40L DC product does indeed lead to restoration of both IL-2 and IFN-? responses. Also consistent with our in vitro observation is the gradual decline of the immune effector T cells in the peripheral circulation (i.e., weaker signal after the fifth dose). This is indicative of T cell effector memory maturation (i.e., CD8+/CD28+/CD45RA- T cells) which are equipped to leave the peripheral circulation and infiltrate the tissues in surveillance of target antigens. It is also noteworthy that presence of CD28+ T cells in tumor lymphocytic infiltrates correlates with favorable clinical outcome.

In contrast to the disease stabilization observed in our first RCC study, using the PME-CD40L DC product we have observed tumor regressions in a number of patients in the current study. At present, 6 of 12 patients that have been restaged using RECIST criteria have less tumor burden that when they enrolled in the study (15 weeks earlier).

created over 15 years ago (2 March 2009)    last modified over 13 years ago (17 October 2011)   [ RDF Rdf ]   [ RelFinder Relfinder ]