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FDA Lifts Clinical Hold on Phase 1/2 Trial Evaluating BPX-601 for Metastatic Pancreatic, Prostate Cancer

The FDA has lifted the clinical hold on patient enrollment and dosing for an ongoing phase 1/2 dose-escalation clinical trial (NCT02744287) evaluating the GoCAR-T product candidate BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer, according to the agent’s developer, Bellicum Pharmaceuticals.1

In response to the clinical hold, Bellicum indicated it worked with the FDA over the past 2 months and was informed by the agency that it has satisfactorily addressed all clinical hold issues. The company can now begin enrolling patients again without modification to the study protocol and plans to work with clinical investigators to do so.

“I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate…

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