T cell receptor gene therapy for leukemia patients

In this project a T cell receptor (TCR) gene therapy study will be performed, in which patients suffering from leukemia will be treated with engineered T cells expressing a tumor specific TCR. Before, LUMC has performed the first Phase I/II gene therapy study for leukemia patients in the Netherlands. Based on the experience and results of this first clinical study a new Phase I/II clinical study will be initiated in collaboration with MDG. MDG has experience with TCR gene therapy, since a Phase I/II clinical study in which patients suffering from acute myeloid leukemia are treated with PRAME-TCR modified T cells is currently running by MDG. The expertise in process development for such a gene modified product is of significant added value to the quality of this project.

In the preclinical phase of this project the production process of the TCR T cell product will be validated and optimized. In the second part of the project a phase I/II clinical study will be performed to test the efficacy and safety of the HA1-TCR T-cell product in patients suffering from relapsed hematological malignancies after allogeneic stem cell transplantation. With this collaboration it will speed up the process of testing and development of a Phase I/II clinical study due to expert expertise in basic immunology, gene therapeutic strategies, presence of the essential reagents  at LUMC, and the expert expertise of MDG in initiating Phase I/II gene therapeutic studies.