Adaptimmune Announces Opening of Pilot Clinical Trial in Synovial Sarcoma
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Adaptimmune has announced that it has opened a Pilot, open-label clinical trial in synovial sarcoma at the National Cancer Institute (NCI), Bethesda, Maryland, testing its enhanced T cell receptor T cell therapy. A second site is planned to open later this year at Washington University, St. Louis, Missouri.
Adaptimmune is focused on the use of T cell therapy to treat cancer, with the body’s own machinery - the T lymphocyte cell - being used to target and destroy cancerous cells.
This trial is designed to investigate the safety, anti-tumor effect and bioactivity of infusion of patients’ own T cells that have been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen).
During the trial, an enhanced T cell receptor will be deployed to target a CT antigen called NYESO-1. T cell manufacturing will be performed at the Clinical Cell and Vaccine Production Facility at the Perelman School of Medicine at the University of Pennsylvania, directed by Dr. Bruce Levine.
Dr. Carl H. June at the Abramson Cancer Center of the University of Pennsylvania and Dr. Crystal Mackall of the Pediatric Oncology Branch of the NCI developed the study design, which was reviewed by the National Institutes of Health Recombinant DNA Advisory Committee last year.
Dr. June is the regulatory sponsor (FDA representative) for the study, and Dr. Mackall is the lead clinical investigator at the NCI. Adaptimmune is the financial sponsor and owns the core T cell receptor engineering technology.
Synovial sarcoma is a rare and high risk soft tissue sarcoma, characterized in most cases with an onset of masses located near joints in the lower extremities, although at times the initial tumors occur in the upper extremities, trunk or neck. The onset of synovial sarcoma typically occurs by the third decade of life, which makes this a particularly grievous cancer.
After first line therapy, which involves surgery and chemotherapy, recurrent unresectable and/or metastatic sarcomas are nearly universally fatal. This clinical trial focuses on this unmet medical need, which includes an estimated 50-70% of patients with synovial sarcoma. Synovial sarcoma is an immunogenic cancer and is therefore an attractive target for immunotherapeutic approaches.
“Prior immunotherapy studies have shown promise against this devastating cancer,” says Dr. June. “With this trial, we aim to enhance response rates over prior studies and reduce treatment toxicities by utilizing commercially feasible advances in the T cell manufacturing process which also allows us to avoid using IL-2 to support survival of the cells in the patient.”
Up to 10 patients will be enrolled in the trial, which may take up to three years to accrue due to the rare nature of the cancer. In addition to evaluating safety, the primary objective of the study is to determine the response rate to the therapy.
Secondary endpoints are to investigate the persistence of the genetically modified cells and to perform analyses of the anti-tumor immune responses in patients.
“I am quite pleased to be working with such an excellent and dedicated investigator for synovial sarcoma” says James Noble, Adaptimmune’s CEO. “This is the third trial we are running with this TCR and if we show enhanced responses in this trial, we envisage broadening our scope to a wider spectrum of sarcomas.”