RCC phase 2 trial

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).

• biomaterial type
• effector T cell

• molecule type
• CD45,
• CD8,
• Interleukin-2,
• CD40 ligand,
• interferon,
• CD28 receptor

• cell type
• dendritic cell,
• effector T cell,
• peripheral blood cell

• organism type
• Homo sapiens

• experimental design type
• in vivo design experiment

created over 16 years ago (2 March 2009)    last modified over 13 years ago (17 October 2011)   [ RDF ]   [ RelFinder ]