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First-of-its-kind clinical trial for new pancreatic cancer immunotherapy underway

Baylor Health Care System Mar 03, 2017

Baylor University Medical Center is only site enrolling patients in new investigational study.
Baylor Scott & White Research Institute has announced a new clinical trial that explores an innovative immunotherapy treatment for pancreatic cancer patients – the first of its kind to enter clinical studies – that allows control over CAR T–cell activity. CAR T–cell immunotherapy involves extracting a patient's immune cells, re–engineering them to target cancer and then infusing them back into patients.

The BPX–601 clinical study, sponsored by Bellicum Pharmaceuticals, Inc., will evaluate the company's new CAR T–cell therapy designed to target solid tumors while giving clinicians control over the expansion and stimulation of the cells using rimiducid, a small molecule activator agent.

Pancreatic cancer is the third leading cause of cancer–related death in the United States, surpassing breast cancer. No detection tools exist to diagnose the disease in its early stages, when it's easier to treat.

"This clinical trial is an important step in our ongoing research efforts to improve patient outcomes in one of the deadliest forms of cancer," said Carlos Becerra, MD, interim chief of oncology at Baylor University Medical Center and principal investigator of the study. "The pancreatic cancer patients who will be eligible to participate in the study have progressed after standard treatments and have limited options. We hope that this trial will be an important step in developing safe and effective CAR T–cell therapy for solid tumors."

The study is an open–label, non–randomized, dose–finding trial designed to evaluate the safety and activity of BPX–601 and rimiducid in up to 30 patients with non–resectable pancreatic adenocarcinoma. Its purpose is to determine the safety of the administration of BPX–601, the safety of the rimiducid infusion and the persistence of the CAR T–cells over time.
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