Adaptimmune announced that it has opened a Phase I/IIa, multiple-site, two-cohort, open-label clinical trial in ovarian cancer at Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., and City of Hope (COH) in Duarte, Calif. The study will evaluate the safety, bioactivity and effectiveness of treating patients with their own T cells that have been genetically engineered to enhance antitumor activity.
Adaptimmune has developed a unique enhancement technology for T cell receptors (TCRs), engineering them to target two cancer/testic (CT) antigens, NYESO-1 and LAGE-1. The TCRs will be transferred to the patients’ T cells in a process for autologous T cell manufacturing developed by Carl June, MD, and Bruce Levine, PhD, at the Perelman School of Medicine at the University of Pennsylvania. The process has been licensed to Adaptimmune and manufacturing will be performed centrally by Progenitor Cell Therapy in Allendale, N.J.
“T cells are the foot soldiers of the human immune system, attacking invaders like bacteria, viruses and cancer,” said Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy and study chair, in a press release. “We believe that by modifying the T cells so that they express a high-affinity receptor for a protein that is a known cancer/testis (CT) antigen, we can fully exploit their ability as cancer killers.”
The study is funded by Adaptimmune, who is the regulatory sponsor and owner of the T cell receptor technology, and will evaluate treatment in patients who are resistant to chemotherapy and/or have received more than two lines of chemotherapy for their ovarian cancer. Positive results have been reported for the same T cell product in sarcoma and myeloma studies earlier this year.
A total of six patients will be enrolled in this ovarian cancer trial. Eligible patients are those who are capable of responding to the therapy (i.e., those with the correct tissue marker (HLA-A*0201) and whose tumor expresses NYESO-1 and/or LAGE-1). More patients will be enrolled if results from this clinical trial are promising. Additional study details can be found at clincialtrials.gov, under trial identifier number NCT01567891.